A JNJ-73763989 + Nucleos(t)ide analóg vizsgálata hepatitis B-vel és Hepatitis D vírussal együtt fertőzött résztvevőknél (REEF-D)
2026. június 24. frissítette: Janssen Research & Development, LLC
2. fázisú, többközpontú, randomizált, kettős vak, placebo-kontrollos vizsgálat elhalasztott aktív kezeléssel a JNJ-73763989 + Nucleos(t)Ide analóg hatékonyságának, biztonságosságának és farmakokinetikájának vizsgálatára hepatitis B-vel és hepatitisszel együtt fertőzött résztvevőknél D Vírus
A vizsgálat célja a JNJ-73763989 + nukleos(t)idanalóg (NA) sémának a hepatitis D vírus (HDV) elleni kezelés közbeni hatékonyságának értékelése az NA önmagában történő kezeléséhez képest.
A tanulmány áttekintése
Állapot
Állapot
Befejezve
Körülmények
Körülmények
Beavatkozás / kezelés
Beavatkozás / kezelés
Részletes leírás
A JNJ-73763989 egy májra célzott vírusellenes terápia szubkután injekcióhoz, amelyet krónikus hepatitis B vírus (HBV) fertőzés kezelésére terveztek ribonukleinsav-interferencia mechanizmuson keresztül.
Ez a 2. fázisú vizsgálat célja a JNJ-73763989 biztonságosságának és hatékonyságának értékelése olyan HBV-fertőzött betegeknél, akik egyidejűleg fertőzöttek HDV-vel.
A tanulmány két részből áll: az 1. rész a JNJ-73763989 + NA biztonságosságát, tolerálhatóságát és vírusellenes aktivitását, míg a 2. rész a JNJ-73763989 + NA kezelési rend biztonságosságát és hatékonyságát értékeli a HBV/HDV társfertőzés kezelésében. .
Mindegyik rész 3 fázisból áll: Szűrési fázis (4 héttől maximum 8 hétig), Beavatkozási szakasz (144 hét az A karnál és 148 hét a B karnál) és nyomon követési szakasz (48 hét).
Az egyéni tanulmányi részvétel időtartama 196 és 204 hét között lesz.
Biztonság és tolerálhatóság (beleértve a nemkívánatos eseményeket [AE] és a súlyos nemkívánatos eseményeket, a laboratóriumi értékeléseket, az elektrokardiogramot [EKG], az életjeleket, a fizikális vizsgálatot), a hatékonyság (beleértve a HDV ribonukleinsavat [RNS], a HBV dezoxiribonukleinsavat [DNS] és az antigéneket) és a farmakokinetikát a vizsgálat során végig értékelik.
Tanulmány típusa
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
Beiratkozás
52
Fázis
Fázis
- 2. fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Camperdown, Ausztrália, 2050
- Royal Prince Alfred Hospital
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Footscray, Ausztrália, 3011
- Western Health
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Westmead, Ausztrália, 2145
- Westmead Hospital
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Boa Vista, Brazília, 69304015
- Centro Oncológico De Roraima
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Manaus, Brazília, 69040-000
- Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
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Porto Velho, Brazília, 76812-329
- Cepem - Centro de Pesquisa Em Medicina Tropical
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London, Egyesült Királyság, SE5 9RF
- Kings College Hospital
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California
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Redwood City, California, Egyesült Államok, 94063
- Stanford University School of Medicine
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Massachusetts
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Boston, Massachusetts, Egyesült Államok, 02114
- Harvard Medical School Massachusetts General Hospital
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Clichy, Franciaország, 92110
- Hopital Beaujon
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Lyon, Franciaország, 69004
- Hôpital de La Croix Rousse
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Nantes, Franciaország, 44093
- CHU de Nantes hotel Dieu
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Paris, Franciaország, 75012
- CHU Hopital Saint Antoine
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Rennes, Franciaország, 35033
- Chu Rennes Hopital Pontchaillou
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Bunkyō City, Japán, 113 8519
- Tokyo Medical and Dental University Hospital
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Hiroshima, Japán, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Iizuka-shi, Japán, 820-8505
- National Hospital Organization Shikoku Cancer Center
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Ikeda, Japán, 563-8510
- Ikeda City Hospital
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Kumamoto, Japán, 860-8556
- Kumamoto University Hospital
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Kumamoto, Japán, 862 8655
- Kumamoto Shinto General Hospital
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Nagasaki, Japán, 852-8501
- Nagasaki University Hospital
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Nagasaki, Japán, 856-8562
- National Hospital Organization Nagasaki Medical Center
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Nakagami Gun, Japán, 903-0215
- University of the Ryukyus hospital
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Okinawa, Japán, 904-2195
- Nakagami Hospital
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Suita, Japán, 564-8567
- Suita Municipal Hospital
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Suita-shi, Japán, 565-0871
- Osaka University Hospital
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Sumida Ku, Japán, 130 8575
- Tokyo Metropolitan Bokutoh Hospital
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Beijing, Kína, 100015
- Beijing Ditan Hospital Capical Medical University
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Beijing, Kína, 100044
- Peking University People s Hospital
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Changchun, Kína, 130021
- The First Bethune Hospital of Jilin University
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Chengdu, Kína, 610041
- West China Hospital Sichuan University
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Chongqing, Kína, 400010
- The Second Affiliated Hospital of Chongqing Medical University
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Guangzhou, Kína, 510515
- Nanfang Hospital
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Guangzhou, Kína, 510000
- Guangzhou Eighth People's Hospital, Guangzhou Medical University
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Hangzhou, Kína, 310003
- The First Affiliated Hospital Zhejiang University College of Medicine
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Shanghai, Kína, 200040
- Huashan Hospital Fudan University
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Essen, Németország, 45147
- Universitätsklinikum Essen
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Frankfurt, Németország, 60590
- Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
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Hanover, Németország, 30625
- Medizinische Hochschule Hannover
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Milan, Olaszország, 20122
- Irccs Ospedale Maggiore Di Milano
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Pisa, Olaszország, 56124
- Azienda Ospedaliero Universitaria Pisana
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Rome, Olaszország, 00161
- Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
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Torino, Olaszország, 10126
- Ospedale Molinette, AO Città della Salute e della Scienza di
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Krasnoyarsk, Oroszország, 660049
- Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
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Saint Petersburg, Oroszország, 190103
- St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
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Samara, Oroszország, 443045
- Medical Company Hepatolog Ltd
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Barcelona, Spanyolország, 8028
- Hosp Clinic de Barcelona
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Barcelona, Spanyolország, 8035
- Hosp Univ Vall D Hebron
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Madrid, Spanyolország, 28041
- Hosp. Univ. 12 de Octubre
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Santander, Spanyolország, 39008
- Hosp. Univ. Marques de Valdecilla
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Danderyd, Svédország, 18288
- Danderyds Sjukhus
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Malmö, Svédország, 20502
- Skånes universitetssjukhus
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Stockholm, Svédország, 14186
- Karolinska Universitetssjukhuset Huddinge
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Kaohsiung City, Tajvan, 80756
- Kaohsiung Medical University Chung Ho Memorial Hospital
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Taipei, Tajvan, 10002
- National Taiwan University Hospital
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Tiachung, Tajvan
- China Medical University Hospital
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Istanbul, Törökország (Türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
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Izmir, Törökország (Türkiye), 35100
- Ege University Medical of Faculty, Department of Gastroenterology
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Kocaeli, Törökország (Türkiye), 41001
- Kocaeli University Medical Faculty
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Trabzon, Törökország (Türkiye), 61080
- Karadeniz Teknik University Medical Faculty
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Auckland, Új Zéland, 1010
- New Zealand Clinical Research
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Leírás
Bevételi kritériumok:
- Orvosilag stabil fizikális vizsgálat, kórelőzmény, életjelek, elektrokardiogram (EKG) alapján a szűréskor
- Krónikus hepatitis B vírus (HBV) és hepatitis D vírus (HDV) együttfertőződés a szűrés előtt legalább 6 hónappal dokumentálva
- Az 1. részhez: a hepatitis D RNS (HDV RNS) legalább (>=) 1000 nemzetközi egység milliliterenként (NE/mL) a szűréskor. A 2. részhez: HDV RNS-értékeknek >= 500 NE/mL-nek kell lenniük, és a hepatitis B felületi antigén (HBsAg) értékének kisebbnek vagy egyenlőnek kell lennie, mint (
- Az alanin-aminotranszferáz (ALT) nagyobb, mint a normál felső határ (ULN), de kevesebb, mint 10-szerese (ULN)
- Testtömeg-index (BMI) 18,0 és 35,0 kilogramm/m² (kg/m^2), a szélsőségeket is beleértve
- Rendkívül hatékony fogamzásgátló intézkedések a fogamzóképes korú női résztvevők vagy a fogamzóképes nő partnerekkel rendelkező férfi résztvevők számára
- A nem cirrózisos résztvevők és a kompenzált májzsugorban szenvedő résztvevők (Child Pugh A osztály) a szűréskor (1. rész), valamint a résztvevőknek cirrhosis hiánya és thrombocytaszáma >= 140 000 deciliterenként (dL) ahhoz, hogy bekerülhessen a 2. részbe.
Kizárási kritériumok:
- A hepatitis A, C vagy E vírusfertőzés bizonyítéka vagy humán immunhiány, 1-es típusú vírus (HIV-1) vagy HIV-2 fertőzés bizonyítéka a szűréskor
- A máj dekompenzációjának klinikai jeleinek/tüneteinek kórtörténete vagy bizonyítéka, beleértve, de nem kizárólagosan: portális hipertónia, ascites, hepatikus encephalopathia, nyelőcső visszér vagy bármely laboratóriumi eltérés, amely a protokollban meghatározott csökkent májfunkcióra utal
- Nem HBV/HDV etiológiájú májbetegség bizonyítéka
- A hepatocelluláris karcinóma (HCC) jelei
- Jelentős laboratóriumi eltérések a szűréskor a jegyzőkönyvben meghatározottak szerint
- Olyan résztvevők, akiknek a kórelőzményében rosszindulatú daganat szerepel a szűrést megelőző 5 éven belül
- Rendellenes sinusritmus vagy EKG-paraméterek a szűréskor a protokollban meghatározottak szerint
- A kórtörténetben vagy jelenlegi szívritmuszavar, vagy jelentős vagy instabil szívbetegség anamnézisében vagy klinikai bizonyítékaiban
- Olyan jelenlegi vagy korábbi betegségben szenvedő résztvevők, akiknél a vizsgálatot végző és/vagy szponzor véleménye szerint a részvétel nem szolgálná a résztvevő legjobb érdekét
- A kórtörténetben vagy a jelenlegi klinikailag jelentős bőrbetegség vagy gyógyszeres kiütés
- A JNJ-3989-re vagy annak segédanyagaira vagy a placebót tartalmazó segédanyagaira ismert allergiában, túlérzékenységben vagy intoleranciában szenvedő résztvevők
- Az entekavir (ETV), a tenofovir-dizoproxil vagy a tenofovir-alafenamid (TAF) alkalmazásának ellenjavallatai a helyi előírás szerint
- Azok a résztvevők, akik bármilyen terápiában részesültek, a protokoll szerint nem engedélyezettek
- Női résztvevők, akik terhesek, szoptatnak, vagy terhességet terveznek, miközben részt vettek ebben a vizsgálatban, vagy a vizsgálati beavatkozás utolsó adagját követő 90 napon belül
- Férfi résztvevők, akik gyermekvállalást terveznek, miközben beiratkoztak
- Olyan résztvevők, akiknél jelentős műtéten esett át vagy terveztek (például általános érzéstelenítést igénylő) vagy szervátültetésen estek át
- Kiszolgáltatott résztvevők (például bebörtönzött személyek, jogi védelmi intézkedés hatálya alá tartozó személyek)
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek száma
2
Fegyverek és beavatkozások
Résztvevő csoport / karRésztvevő csoport / kar |
Beavatkozás / kezelésBeavatkozás / kezelés |
|---|---|
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Kísérleti: Azonnali aktív kezelési kar: JNJ-73763989 + NA
A résztvevők JNJ-73763989 szubkután (SC) injekciót kapnak 4 hetente (Q4W), valamint NA-t (entecavir [ETV], tenofovir-dizoproxil vagy tenofovir-alafenamid [TAF]) naponta egyszer 144 héten keresztül az 1. részben és legalább 96 héten keresztül. a 2. részben.
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A Tenofovir disoproxil filmtablettát szájon át kell bevenni.
A JNJ-73763989 szubkután injekció formájában kerül beadásra.
Más nevek:
Az ETV monohidrát filmtablettát szájon át kell beadni.
A TAF filmtablettát szájon át kell beadni.
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Placebo Comparator: Elhalasztott aktív kezelési kar: Placebo+NA+JNJ-73763989+NA
A résztvevők a JNJ-73763989 Q4W SC injekcióhoz megfelelő placebót kapnak NA-val (ETV, tenofovir-dizoproxil vagy TAF) együtt naponta egyszer 52 héten keresztül, majd JNJ-73763989 SC Q4W injekciót kapnak naponta egyszer NA-val együtt 96 héten keresztül az 1. részben. legalább 48 hét a 2. részben.
|
A Tenofovir disoproxil filmtablettát szájon át kell bevenni.
A JNJ-73763989 szubkután injekció formájában kerül beadásra.
Más nevek:
Az ETV monohidrát filmtablettát szájon át kell beadni.
A TAF filmtablettát szájon át kell beadni.
A JNJ-73763989-hez illő placebót SC injekcióként adják be.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Double-blind:Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Időkeret: Week 48
|
Percentage of participants with hepatitis D virus (HDV) RNA greater than or equal to (>=) 2 log10 international units per milliliter (IU/mL) decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT less than (<) upper limit of normal (ULN) with ULN = 34 units per liter (U/L) for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT at Week 48 (Multiple Imputation Approach)
Időkeret: Week 48
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT at Week 48 using multiple imputation approach was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Másodlagos eredményintézkedések
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Parts 1 and 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA < Lower Limits of Quantification (LLOQ) at Week 48
Időkeret: Week 48
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA < LLOQ at Week 48 was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
|
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Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48
Időkeret: Week 48
|
Percentage of participants with normal ALT at Week 48 was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Week 48
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Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48
Időkeret: Week 48
|
Percentage of participants with HBsAg seroclearance at Week 48 was reported.
HBsAg seroclearance was defined as HBsAg negativity (quantitative HBsAg level <LLOQ) based on the assay used.
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Week 48
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Parts 1 and 2: Percentage of Participants With >=2 Kilopascal (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE) (FibroScan) at Week 48
Időkeret: Week 48
|
Percentage of participants with >=2 kPa reduction from baseline in LSM assessed by VCTE (fibroscan) at Week 48 was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Week 48
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Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Időkeret: Week 48, FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48, FU Week 24
|
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Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Időkeret: Week 48, FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48, FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination With Normal ALT
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA TND in combination with normal ALT was reported.
Normal ALT is defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
TND was defined as no traces of HBV RNA were detected/found.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA TND in Combination With Normal ALT
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA TND in combination with normal ALT was reported.
TND was defined as no traces of HBV RNA were detected/found.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Időkeret: Week 48 and FU Week 24
|
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Week 48 and FU Week 24
|
|
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Időkeret: Week 48 and FU Week 24
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Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Week 48 and FU Week 24
|
|
Part 1: Percentage of Participants With HDV RNA TND
Időkeret: Week 48, FU Week 24
|
Percentage of participants with HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
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Week 48, FU Week 24
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Part 2: Percentage of Participants With HDV RNA TND
Időkeret: Week 48, FU Week 24
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Percentage of participants with HDV RNA TND was reported.
TND was defined as no traces of HBV RNA were detected/found.
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Week 48, FU Week 24
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Part 1: Percentage of Participants With Normal ALT
Időkeret: FU Week 24
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Percentage of participants with Normal ALT was reported.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
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FU Week 24
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Part 2: Percentage of Participants With Normal ALT
Időkeret: FU Week 24
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Percentage of participants with Normal ALT was reported.
Normal ALT was defined as ALT <ULN with ULN = 34 U/L for female and 43 U/L for male.
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FU Week 24
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Parts 1 and 2: Time to Reach HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Időkeret: Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
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Time to reach HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND was planned to be reported.
It is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HDV RNA >= 2 log10 IU/mL decline or HDV RNA TND, whichever event is first (that is, minute [the date of the first HDV RNA >= 2 log10 IU/mL decline, date of the first time HDV RNA is TND] - the date of first study intervention intake + 1).
TND was defined as no traces of HBV RNA were detected/found.
The multiple imputation approach was derived using a longitudinal multiple regression model to impute missing data.
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Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
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Part 1: Change From Baseline in HDV RNA
Időkeret: Baseline (Day 1), Week 48
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Change from baseline in HDV RNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48
|
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Part 2: Change From Baseline in HDV RNA
Időkeret: Baseline (Day 1), Week 48
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Change from baseline in HDV RNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48
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Part 1: Change From Baseline in ALT
Időkeret: Baseline (Day 1), Week 48, FU Week 24
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Change from baseline in ALT was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48, FU Week 24
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Part 2: Change From Baseline in ALT
Időkeret: Baseline (Day 1), Week 48, FU Week 44
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Change from baseline in ALT was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline (Day 1), Week 48, FU Week 44
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Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with TEAEs was reported.
An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention.
TEAE were all AEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with TESAEs was reported.
SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
TESAE were all SAEs with a start date on or after the first administration of study treatment or any ongoing event that worsens in severity, intensity or frequency after the first administration of study treatment.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: chemistry was reported.
Laboratory abnormalities were graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
ALT: Alanine Aminotransferase; AST: Aspartate Aminotransferase; SGPT: serum glutamic pyruvic transaminase; SGOT: serum glutamic-oxaloacetic transaminase.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Hematology
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
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Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: hematology was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
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Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urinalysis was reported.
Urinalysis included parameters: Glycosuria, Hematuria, and Proteinuria.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: urine chemistry was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with worst treatment-emergent abnormalities in clinical laboratory tests: renal biomarkers was reported.
Laboratory abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with worst treatment-emergent abnormalities in 12-Lead Electrocardiogram was reported.
Only those parameters were reported where at least one participant had abnormality.
Worst ECG abnormalities were determined based on investigator's discretion.
bpm: beats per minute; ms: milliseconds; QTcF: QT interval corrected for heart rate according to Fridericia; QTc: Corrected QT Interval.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144
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Percentage of participants with worst treatment-emergent abnormalities in vital signs (pulse rate, supine systolic blood pressure).
Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
Only Grade 3 and Grade 4 abnormalities were considered worst and are reported.
Only those laboratory parameters for which at least one participant had an abnormality are reported in this outcome measure.
Only those parameters were reported where at least one participant had abnormality.
Abn: abnormal
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144
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Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
Időkeret: Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Percentage of participants with clinically significant abnormalities in physical examination was reported.
Vital signs abnormalities were graded according to the DAIDS criteria as follows: Grade 1 - Mild, Grade 2 - Moderate, Grade 3 - Severe, and Grade 4 - Potentially life threatening.
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Placebo + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 148, FUP Phase: Week 148 up to Week 196; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52, OL Phase: Week 52 up to Week 144; FUP Phase: Week 144 up to Week 192
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Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBsAg seroclearance was reported.
HBsAg seroclearance is defined as the quantitative HBsAg < LLOQ.
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Week 48, FU Week 24
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Part 1: Change From Baseline Over Time in HBsAg
Időkeret: Baseline (Day 1), Week 48, FU Week 24
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Change from baseline over time in HBsAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48, FU Week 24
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Part 2: Change From Baseline Over Time in HBsAg
Időkeret: Baseline (Day 1), Week 48, FU Week 24
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Change from baseline over time in HBsAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48, FU Week 24
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Part 1: Change From Baseline Over Time in Hepatitis B Virus e Antigen (HBeAg)
Időkeret: Baseline (Day 1), Week 48, FU Week 24
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Change from baseline over time in HBeAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48, FU Week 24
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Part 2: Change From Baseline Over Time in HBeAg
Időkeret: Baseline (Day 1), Week 48, FU Week 24
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Change from baseline over time in HBeAg was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Week 48, FU Week 24
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Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Időkeret: Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
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Change from baseline over time in HBV DNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
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Part 2: Change From Baseline Over Time in HBV DNA
Időkeret: Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
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Change from baseline over time in HBV DNA was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
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Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBsAg levels below/above different cut-offs was reported.
HBsAg values (IU/mL) were <1,000, <100, <10, <1, and <0.05 IU/mL (i.e, <LLOQ).
LLOQ value is 0.05 IU/mL.
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Week 48, FU Week 24
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Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBsAg levels below/above different cut-offs was reported.
HBsAg values (IU/mL) were <1,000, <100, <10, <1, and <0.05 IU/mL (i.e, <LLOQ).
LLOQ value is 0.05 IU/mL.
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Week 48, FU Week 24
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Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBeAg levels below/above different cut-offs was reported.
Cut-offs were >= 0.5 log10 IU/mL, >= 1.0 log10 IU/mL, >= 2.0 log10 IU/mL, and >= 3.0 log10 IU/mL.
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Week 48, FU Week 24
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Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBeAg levels below/above different cut-offs was reported.
Cut-offs were >= 0.5 log10 IU/mL, >= 1.0 log10 IU/mL, >= 2.0 log10 IU/mL, and >= 3.0 log10 IU/mL.
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Week 48, FU Week 24
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Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBV DNA levels below/above different cut-offs (<LLOQ and <2000 IU/mL) was reported.
For HBV DNA, LLOQ is 20 IU/mL.
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Week 48, FU Week 24
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Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBV DNA levels below/above different cut-offs (<LLOQ and <2000 IU/mL).
For HBV DNA, LLOQ is 20 IU/mL
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Week 48, FU Week 24
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Part 1: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Időkeret: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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Time to reach HBsAg <1 IU/mL based on Kaplan-Meier estimate was reported.
Time to first occurrence of the HBsAg <1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg <1 IU/mL.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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Part 2: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Időkeret: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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Time to reach HBsAg <1 IU/mL based on Kaplan-Meier estimate was reported.
Time to first occurrence of the HBsAg <1 IU/mL is defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBsAg <1 IU/mL.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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Part 1: Percentage of Participants With HBV DNA Virologic Breakthrough
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBV DNA virologic breakthrough was reported.
Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level <LLOQ of the HBV DNA assay.
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Week 48, FU Week 24
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Part 2: Percentage of Participants With HBV DNA Virologic Breakthrough
Időkeret: Week 48, FU Week 24
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Percentage of participants with HBV DNA virologic breakthrough was reported.
Virologic Breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had HBV DNA level <LLOQ of the HBV DNA assay.
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Week 48, FU Week 24
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Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Időkeret: Weeks 4, 8, and 16
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Maximum plasma concentration (Cmax) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
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Weeks 4, 8, and 16
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Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Időkeret: Weeks 4, 8, and 16
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Maximum plasma concentration (Cmax) of JNJ-3924 was reported.
Participant wise data is reported as n<3.
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Weeks 4, 8, and 16
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Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Időkeret: Predose up to 24 hours post dose on Weeks 4, 8, and 16
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Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[0-24h]) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
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Predose up to 24 hours post dose on Weeks 4, 8, and 16
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Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Időkeret: Predose up to 24 hours post dose on Weeks 4, 8, and 16
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Area under the plasma concentration-time curve from time 0 to 24 hours (AUC[0-24h]) of JNJ-3924 were reported.
Participant wise data is reported as n<3.
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Predose up to 24 hours post dose on Weeks 4, 8, and 16
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Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Időkeret: Weeks 4, 8, and 16
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Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976 were reported.
Participant wise data is reported as n<3.
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Weeks 4, 8, and 16
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Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Időkeret: Weeks 4, 8, and 16
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Area under the plasma concentration-time curve from time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924 were reported.
Participant wise data is reported as n<3.
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Weeks 4, 8, and 16
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Part 1: Percentage of Participants With >=2 Kilopascals (kPa) Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by Vibration-controlled Transient Elastography (VCTE; FibroScan)
Időkeret: Baseline, EOS (FU Week 48)
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Percentage of participants with >=2 kPa reduction from baseline >=2 kPa in liver stiffness measurement (LSM) assessed by VCTE (fibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline, EOS (FU Week 48)
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Part 2: Percentage of Participants With >=2 kPa Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by VCTE (FibroScan)
Időkeret: Baseline, EOS (FU Week 48)
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Percentage of participants with >=2 kPa reduction from baseline in liver stiffness measurement (LSM) assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
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Baseline, EOS (FU Week 48)
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Part 1: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Időkeret: Baseline, Week 48, FU Week 24
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Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline, Week 48, FU Week 24
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Part 2: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Időkeret: Baseline, Week 48, FU Week 24
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Change from baseline in LSM over time assessed by VCTE (FibroScan) was reported.
The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study intervention on Day 1.
|
Baseline, Week 48, FU Week 24
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Part 1: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported.
A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Part 2: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with sustained HDV response Off-treatment post end of JNJ-3989 treatment was reported.
A JNJ-3989 off-treatment sustained HDV response is defined by having HDV RNA TND during the FU phase after stopping JNJ-3989 regardless of continuing NA treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Part 1: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported.
Off-treatment HDV relapse is defined as: 1.
In participants with HDV RNA <LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment.
2. In participants with HDV RNA >LLOQ at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Part 2: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with HDV relapse post end of JNJ-3989 treatment was reported.
Off-treatment HDV relapse is defined as: 1.
In participants with HDV RNA <LLOQ (i.e., 630 IU/ml) at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL above the LLOQ JNJ-3989 off-treatment.
2. In participants with HDV RNA >LLOQ at EOT: Confirmed increase in HDV RNA of > 1 log10 IU/mL from EOT HDV RNA value JNJ-3989 off-treatment.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Parts 1 and 2: Percentage of Participants With Sustained HBV Response Off-treatment Post End of JNJ-3989 Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with sustained HBV response off-treatment post end of JNJ-3989 treatment was reported.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported.
Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA).
Virologic flare is for participants who are off-treatment and had HBV DNA < LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL.
Biochemical HBV flare is defined as a confirmed ALT and/or AST>=3*ULN and >=3* nadir (i.e.
lowest value observed up to the time point of meeting the biochemical flare criteria).
An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Időkeret: JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
|
Percentage of participants with HBV flare (Virologic, biochemical, and clinical) post end of treatment was reported was reported.
Off-treatment is defined as the time period as the periods when the participants do not receive any of the study interventions (JNJ-3989/placebo and NA).
Virologic flare (Derivation 1) is for participants who are off-treatment and had HBV DNA < LLOQ at the last observed point on all study treatments, and categorized based on the confirmed (i.e., two consecutive values) peak HBV DNA above any of the three thresholds: 20000 IU/mL, 2000 IU/mL and 200 IU/mL.
Biochemical HBV flare is defined as a confirmed ALT and/or AST>=3*ULN and >=3* nadir (i.e.
lowest value observed up to the time point of meeting the biochemical flare criteria).
An HBV clinical flare occurs either when an HBV virologic flare and off-treatment HBV biochemical flare overlap in time or when a HBV biochemical flare starts within 4 weeks following the end of an HBV virologic flare.
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JNJ-73763989 (JNJ-3989) + Nucleos(t)Ide Analog (NA): Post end of treatment (Week 144) up to FU Week 48; Placebo + NA: Post end of treatment (Week 148) up to FU Week 48
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Szponzor
Nyomozók
Nyomozók
- Tanulmányi igazgató: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Tanulmány kezdete
2020. szeptember 17.
Elsődleges befejezés (Tényleges)
Elsődleges befejezés
2023. október 19.
A tanulmány befejezése (Tényleges)
A tanulmány befejezése
2025. március 5.
Tanulmányi regisztráció dátumai
Először benyújtva
Először benyújtva
2020. augusztus 28.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2020. szeptember 1.
Első közzététel (Tényleges)
Első közzététel
2020. szeptember 2.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Utolsó frissítés közzétéve
2026. július 22.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. június 24.
Utolsó ellenőrzés
Utolsó ellenőrzés
2026. június 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
- Patológiás folyamatok
- Krónikus betegség
- Betegség tulajdonságai
- Fertőzések
- RNS vírusfertőzések
- Vírusos betegségek
- Emésztőrendszeri betegségek
- Májbetegségek
- Hepatitis, vírusos, emberi
- Hepatitis, krónikus
- Májgyulladás
- Kóros állapotok, jelek és tünetek
- Hepatitis D
- Hepatitis D, krónikus
- Szerves vegyi anyagok
- Heterociklusos vegyületek
- Heterociklusos vegyületek, 2 gyűrű
- Heterociklusos vegyületek, olvasztott gyűrű
- Purinák
- Szerves foszfor vegyületek
- Szerves foszfonátok
- Adenin
- Tenofovir
- tenofovir alafenamid
- entecavir
Egyéb vizsgálati azonosító számok
Egyéb vizsgálati azonosító számok
- CR108868
- 2020-001249-37 (EudraCT szám)
- 73763989HPB2004 (Egyéb azonosító: Janssen Research & Development, LLC)
- 2023-506763-33-00 (Registry Identifier: EUCT number)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
A Janssen Pharmaceutical Companies of Johnson & Johnson adatmegosztási szabályzata a www.janssen.com/clinical-trials/transparency címen érhető el.
Amint az ezen az oldalon olvasható, a vizsgálati adatokhoz való hozzáférés iránti kérelmeket a Yale Open Data Access (YODA) projekt webhelyén keresztül lehet benyújtani a yoda.yale.edu címen.
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Igen
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Nem
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .