Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

En studie av JNJ-73763989 + Nucleos(t)Ide Analog hos deltagare som samtidigt är infekterade med hepatit B och hepatit D-virus (REEF-D)

24 juni 2026 uppdaterad av: Janssen Research & Development, LLC

En fas 2, multicenter, randomiserad, dubbelblind, placebokontrollerad studie med uppskjuten aktiv behandling för att undersöka effektiviteten, säkerheten och farmakokinetiken hos JNJ-73763989 + Nucleos(t)Ide Analog hos deltagare som samtidigt är infekterade med hepatit B och hepatit D Virus

Syftet med studien är att utvärdera effekt vid behandling mot hepatit D-virus (HDV) av JNJ-73763989 + nukleos(t)ide analog (NA) regim jämfört med enbart NA.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

JNJ-73763989 är ett leverinriktat antiviralt läkemedel för subkutan injektion utformat för att behandla kronisk hepatit B-virusinfektion (HBV) via ribonukleinsyrainterferensmekanism. Denna fas 2-studie är utformad för att utvärdera säkerhet och effekt av JNJ-73763989 hos HBV-infekterade patienter som samtidigt är infekterade med HDV. Studien består av 2 delar: Del 1 kommer att utvärdera säkerhet, tolerabilitet och antiviral aktivitet för JNJ-73763989 + NA medan del 2 kommer att utvärdera säkerheten och effekten av JNJ-73763989 + NA-regimen vid behandling av HBV/HDV-saminfektion . Varje del inkluderar 3 faser: Screeningsfas (från 4 veckor upp till maximalt 8 veckor), interventionsfas (144 veckor för arm A och 148 veckor för arm B) och uppföljningsfas (48 veckor). Varaktigheten av individuellt studiedeltagande kommer att vara mellan 196 och 204 veckor. Säkerhet och tolerabilitet (inklusive biverkningar [AE] och allvarliga AE, laboratoriebedömningar, elektrokardiogram [EKG], vitala tecken, fysisk undersökning), effekt (inklusive HDV-ribonukleinsyra [RNA], HBV-deoxiribonukleinsyra [DNA] och antigener) och farmakokinetiken kommer att bedömas under hela studien.

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Australien
      • Camperdown, Australien, 2050
        • Royal Prince Alfred Hospital
      • Footscray, Australien, 3011
        • Western Health
      • Westmead, Australien, 2145
        • Westmead Hospital
  • Brasilien
      • Boa Vista, Brasilien, 69304015
        • Centro Oncológico De Roraima
      • Manaus, Brasilien, 69040-000
        • Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
      • Porto Velho, Brasilien, 76812-329
        • Cepem - Centro de Pesquisa Em Medicina Tropical
  • Frankrike
      • Clichy, Frankrike, 92110
        • Hopital Beaujon
      • Lyon, Frankrike, 69004
        • Hôpital de La Croix Rousse
      • Nantes, Frankrike, 44093
        • CHU de Nantes hotel Dieu
      • Paris, Frankrike, 75012
        • CHU Hopital Saint Antoine
      • Rennes, Frankrike, 35033
        • Chu Rennes Hopital Pontchaillou
  • Förenta staterna
    • California
      • Redwood City, California, Förenta staterna, 94063
        • Stanford University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Harvard Medical School Massachusetts General Hospital
  • Italien
      • Milan, Italien, 20122
        • Irccs Ospedale Maggiore Di Milano
      • Pisa, Italien, 56124
        • Azienda Ospedaliero Universitaria Pisana
      • Rome, Italien, 00161
        • Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
      • Torino, Italien, 10126
        • Ospedale Molinette, AO Città della Salute e della Scienza di
  • Japan
      • Bunkyō City, Japan, 113 8519
        • Tokyo Medical and Dental University Hospital
      • Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
      • Iizuka-shi, Japan, 820-8505
        • National Hospital Organization Shikoku Cancer Center
      • Ikeda, Japan, 563-8510
        • Ikeda City Hospital
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kumamoto, Japan, 862 8655
        • Kumamoto Shinto General Hospital
      • Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Nagasaki, Japan, 856-8562
        • National Hospital Organization Nagasaki Medical Center
      • Nakagami Gun, Japan, 903-0215
        • University of the Ryukyus hospital
      • Okinawa, Japan, 904-2195
        • Nakagami Hospital
      • Suita, Japan, 564-8567
        • Suita Municipal Hospital
      • Suita-shi, Japan, 565-0871
        • Osaka University Hospital
      • Sumida Ku, Japan, 130 8575
        • Tokyo Metropolitan Bokutoh Hospital
  • Kina
      • Beijing, Kina, 100015
        • Beijing Ditan Hospital Capical Medical University
      • Beijing, Kina, 100044
        • Peking University People s Hospital
      • Changchun, Kina, 130021
        • The First Bethune Hospital of Jilin University
      • Chengdu, Kina, 610041
        • West China Hospital Sichuan University
      • Chongqing, Kina, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
      • Guangzhou, Kina, 510515
        • Nanfang Hospital
      • Guangzhou, Kina, 510000
        • Guangzhou Eighth People's Hospital, Guangzhou Medical University
      • Hangzhou, Kina, 310003
        • The First Affiliated Hospital Zhejiang University College of Medicine
      • Shanghai, Kina, 200040
        • Huashan Hospital Fudan University
  • Nya Zeeland
      • Auckland, Nya Zeeland, 1010
        • New Zealand Clinical Research
  • Ryssland
      • Krasnoyarsk, Ryssland, 660049
        • Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
      • Saint Petersburg, Ryssland, 190103
        • St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
      • Samara, Ryssland, 443045
        • Medical Company Hepatolog Ltd
  • Spanien
      • Barcelona, Spanien, 8028
        • Hosp Clinic de Barcelona
      • Barcelona, Spanien, 8035
        • Hosp Univ Vall D Hebron
      • Madrid, Spanien, 28041
        • Hosp. Univ. 12 de Octubre
      • Santander, Spanien, 39008
        • Hosp. Univ. Marques de Valdecilla
  • Storbritannien
      • London, Storbritannien, SE5 9RF
        • Kings College Hospital
  • Sverige
      • Danderyd, Sverige, 18288
        • Danderyds Sjukhus
      • Malmö, Sverige, 20502
        • Skånes universitetssjukhus
      • Stockholm, Sverige, 14186
        • Karolinska Universitetssjukhuset Huddinge
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung Ho Memorial Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Tiachung, Taiwan
        • China Medical University Hospital
  • Turkiet (Türkiye)
      • Istanbul, Turkiet (Türkiye), 34098
        • Istanbul University Cerrahpasa Medical Faculty
      • Izmir, Turkiet (Türkiye), 35100
        • Ege University Medical of Faculty, Department of Gastroenterology
      • Kocaeli, Turkiet (Türkiye), 41001
        • Kocaeli University Medical Faculty
      • Trabzon, Turkiet (Türkiye), 61080
        • Karadeniz Teknik University Medical Faculty
  • Tyskland
      • Essen, Tyskland, 45147
        • Universitätsklinikum Essen
      • Frankfurt, Tyskland, 60590
        • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
      • Hanover, Tyskland, 30625
        • Medizinische Hochschule Hannover

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Medicinskt stabil baserat på fysisk undersökning, sjukdomshistoria, vitala tecken, elektrokardiogram (EKG) vid screening
  • Kronisk hepatit B-virus (HBV) och hepatit D-virus (HDV) samtidig infektion med dokumentation minst 6 månader före screening
  • För del 1: hepatit D RNA (HDV RNA) större än eller lika med (>=) 1000 internationella enheter per milliliter (IE/ml) vid screening. För del 2: måste ha HDV RNA-värden >= 500 IE/mL och måste ha hepatit B-ytantigen (HBsAg) värden mindre än eller lika med (
  • Alaninaminotransferas (ALT) högre än den övre normalgränsen (ULN) men mindre än 10 gånger (ULN)
  • Body mass index (BMI) mellan 18,0 och 35,0 kilogram per kvadratmeter kvadrat (kg/m^2), extremer inkluderade
  • Mycket effektiva preventivmedel på plats för kvinnliga deltagare i fertil ålder eller manliga deltagare med kvinnliga partner i fertil ålder
  • Icke-cirrosedeltagare och deltagare med kompenserad cirrhos (Child Pugh klass A) vid screening (del 1) och deltagare måste ha frånvaro av cirros och trombocytantal på >= 140 000 per deciliter (dL) för inskrivning i del-2

Exklusions kriterier:

  • Bevis på infektion med hepatit A-, C- eller E-virusinfektion eller tecken på human immunbrist, virus typ 1 (HIV-1) eller HIV-2-infektion vid screening
  • Historik eller tecken på kliniska tecken/symtom på leverdekompensation inklusive men inte begränsat till: portal hypertoni, ascites, hepatisk encefalopati, esofagusvaricer eller andra laboratorieavvikelser som indikerar nedsatt leverfunktion enligt definitionen i protokollet
  • Bevis på leversjukdom av icke-HBV/HDV-etiologi
  • Tecken på hepatocellulärt karcinom (HCC)
  • Signifikanta laboratorieavvikelser enligt definitionen i protokollet vid screening
  • Deltagare med en historia av malignitet inom 5 år före screening
  • Onormal sinusrytm eller EKG-parametrar vid screening enligt definitionen i protokollet
  • Historik med eller aktuell hjärtarytmi eller historia eller kliniska bevis på signifikant eller instabil hjärtsjukdom
  • Deltagare med någon pågående eller tidigare sjukdom för vilken, enligt utredarens och/eller sponsorns åsikt, deltagande inte skulle vara i deltagarens bästa intresse
  • Historik med eller aktuell kliniskt signifikant hudsjukdom eller läkemedelsutslag
  • Deltagare med känd allergi, överkänslighet eller intolerans mot JNJ-3989 eller dess hjälpämnen eller hjälpämnen i placeboinnehållet
  • Kontraindikationer för användning av entecavir (ETV), tenofovirdisoproxil eller tenofoviralafenamid (TAF) enligt lokal förskrivningsinformation
  • Deltagare som har tagit några terapier är inte tillåtna enligt protokoll
  • Kvinnliga deltagare som är gravida, ammar eller planerar att bli gravida medan de är inskrivna i denna studie eller inom 90 dagar efter den sista dosen av studieinterventionen
  • Manliga deltagare som planerar att skaffa barn medan de är inskrivna
  • Deltagare som genomgått eller planerat en större operation (exempelvis som kräver generell anestesi) eller som har genomgått en organtransplantation
  • Sårbara deltagare (exempelvis fängslade individer, individer under en rättsskyddsåtgärd)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Omedelbar aktiv behandlingsarm: JNJ-73763989 + NA
Deltagarna kommer att få JNJ-73763989 subkutan (SC) injektion var 4:e vecka (Q4W) tillsammans med NA (entecavir [ETV], tenofovirdisoproxil eller tenofoviralafenamid [TAF]) en gång dagligen i 144 veckor i del 1 och i minst 96 veckor i del 2.
Läkemedel: Tenofovirdisoproxil
Tenofovirdisoproxil filmdragerad tablett kommer att administreras oralt.
Läkemedel: JNJ-73763989
JNJ-73763989 kommer att administreras som en SC-injektion.
Andra namn:
  • JNJ-3989
Läkemedel: Entecavir (ETV) monohydrat
ETV monohydrat filmdragerad tablett kommer att administreras oralt.
Läkemedel: Tenofoviralafenamid (TAF)
TAF filmdragerad tablett kommer att administreras oralt.
Placebo-jämförare: Uppskjuten aktiv behandlingsarm: Placebo+NA+JNJ-73763989+NA
Deltagarna kommer att få matchande placebo till JNJ-73763989 SC-injektion Q4W tillsammans med NA (ETV, tenofovirdisoproxil eller TAF) en gång dagligen i 52 veckor följt av JNJ-73763989 SC-injektion Q4W tillsammans med NA en gång dagligen i 916 veckor och under del minst 48 veckor i del 2.
Läkemedel: Tenofovirdisoproxil
Tenofovirdisoproxil filmdragerad tablett kommer att administreras oralt.
Läkemedel: JNJ-73763989
JNJ-73763989 kommer att administreras som en SC-injektion.
Andra namn:
  • JNJ-3989
Läkemedel: Entecavir (ETV) monohydrat
ETV monohydrat filmdragerad tablett kommer att administreras oralt.
Läkemedel: Tenofoviralafenamid (TAF)
TAF filmdragerad tablett kommer att administreras oralt.
Läkemedel: Placebo
Matchande placebo till JNJ-73763989 kommer att administreras som en SC-injektion.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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)
Tidsram: 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.
Week 48
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)
Tidsram: 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.
Week 48

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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
Tidsram: 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.
Week 48
Parts 1 and 2: Percentage of Participants With Normal ALT at Week 48
Tidsram: 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.
Week 48
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 48
Tidsram: 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.
Week 48
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
Tidsram: 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.
Week 48
Part 1: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Tidsram: 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 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With Normal ALT
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Week 48 and FU Week 24
Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline
Tidsram: 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.
Week 48 and FU Week 24
Part 1: Percentage of Participants With HDV RNA TND
Tidsram: 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.
Week 48, FU Week 24
Part 2: Percentage of Participants With HDV RNA TND
Tidsram: 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.
Week 48, FU Week 24
Part 1: Percentage of Participants With Normal ALT
Tidsram: FU Week 24
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.
FU Week 24
Part 2: Percentage of Participants With Normal ALT
Tidsram: FU Week 24
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.
FU Week 24
Parts 1 and 2: Time to Reach HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Tidsram: Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
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.
Placebo + NA: From Day 1 up to Week 196; JNJ-3989 + NA: From Day 1 up to Week 192
Part 1: Change From Baseline in HDV RNA
Tidsram: Baseline (Day 1), Week 48
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
Part 2: Change From Baseline in HDV RNA
Tidsram: Baseline (Day 1), Week 48
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
Part 1: Change From Baseline in ALT
Tidsram: Baseline (Day 1), Week 48, FU Week 24
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 24
Part 2: Change From Baseline in ALT
Tidsram: Baseline (Day 1), Week 48, FU Week 44
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
Parts 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Chemistry
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Hematology
Tidsram: Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
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.
Placebo + NA: DB Phase: Week 0 up to Week 52; JNJ-3989 + NA: DB Phase: Week 0 up to Week 52
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urinalysis
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Urine Chemistry
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Clinical Laboratory Tests: Renal Biomarkers
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in 12-Lead Electrocardiogram
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Worst Treatment-emergent Abnormalities in Vital Signs
Tidsram: 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
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
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
Parts 1 and 2: Percentage of Participants With Clinically Significant Abnormalities in Physical Examination
Tidsram: 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
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.
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
Parts 1 and 2: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance
Tidsram: Week 48, FU Week 24
Percentage of participants with HBsAg seroclearance was reported. HBsAg seroclearance is defined as the quantitative HBsAg < LLOQ.
Week 48, FU Week 24
Part 1: Change From Baseline Over Time in HBsAg
Tidsram: Baseline (Day 1), Week 48, FU Week 24
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.
Baseline (Day 1), Week 48, FU Week 24
Part 2: Change From Baseline Over Time in HBsAg
Tidsram: Baseline (Day 1), Week 48, FU Week 24
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.
Baseline (Day 1), Week 48, FU Week 24
Part 1: Change From Baseline Over Time in Hepatitis B Virus e Antigen (HBeAg)
Tidsram: Baseline (Day 1), Week 48, FU Week 24
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.
Baseline (Day 1), Week 48, FU Week 24
Part 2: Change From Baseline Over Time in HBeAg
Tidsram: Baseline (Day 1), Week 48, FU Week 24
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.
Baseline (Day 1), Week 48, FU Week 24
Part 1: Change From Baseline Over Time in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Tidsram: Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
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.
Baseline (Day 1), Weeks 48 , 136, EOS (FU Week 48)
Part 2: Change From Baseline Over Time in HBV DNA
Tidsram: Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
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.
Baseline (Day 1), Weeks 48, 112, EOS (FU Week 48)
Part 1: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 2: Percentage of Participants With HBsAg Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 1: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 2: Percentage of Participants With HBeAg Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 1: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 2: Percentage of Participants With HBV DNA Levels Below/Above Different Cut-offs
Tidsram: Week 48, FU Week 24
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
Week 48, FU Week 24
Part 1: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Tidsram: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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.
Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
Part 2: Time to Reach HBsAg <1 IU/mL Based on Kaplan-Meier Estimate
Tidsram: Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
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.
Placebo + NA: From baseline up to Week 196; JNJ-3989 + NA: From baseline up to Week 192
Part 1: Percentage of Participants With HBV DNA Virologic Breakthrough
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Part 2: Percentage of Participants With HBV DNA Virologic Breakthrough
Tidsram: Week 48, FU Week 24
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.
Week 48, FU Week 24
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3976
Tidsram: Weeks 4, 8, and 16
Maximum plasma concentration (Cmax) of JNJ-3976 were reported. Participant wise data is reported as n<3.
Weeks 4, 8, and 16
Parts 1 and 2: Maximum Plasma Concentration (Cmax) of JNJ-3924
Tidsram: Weeks 4, 8, and 16
Maximum plasma concentration (Cmax) of JNJ-3924 was reported. Participant wise data is reported as n<3.
Weeks 4, 8, and 16
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3976
Tidsram: Predose up to 24 hours post dose on Weeks 4, 8, and 16
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.
Predose up to 24 hours post dose on Weeks 4, 8, and 16
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-3924
Tidsram: Predose up to 24 hours post dose on Weeks 4, 8, and 16
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.
Predose up to 24 hours post dose on Weeks 4, 8, and 16
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3976
Tidsram: Weeks 4, 8, and 16
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.
Weeks 4, 8, and 16
Parts 1 and 2: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Time (AUC[0-last]) of JNJ-3924
Tidsram: Weeks 4, 8, and 16
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.
Weeks 4, 8, and 16
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)
Tidsram: Baseline, EOS (FU Week 48)
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.
Baseline, EOS (FU Week 48)
Part 2: Percentage of Participants With >=2 kPa Reduction From Baseline in Liver Stiffness Measurement (LSM) Assessed by VCTE (FibroScan)
Tidsram: Baseline, EOS (FU Week 48)
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.
Baseline, EOS (FU Week 48)
Part 1: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Tidsram: Baseline, Week 48, FU Week 24
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
Part 2: Change From Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Tidsram: Baseline, Week 48, FU Week 24
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
Part 1: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Tidsram: 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 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.
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
Part 2: Percentage of Participants With Sustained HDV Response Off-treatment Post End of JNJ-3989 Treatment
Tidsram: 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 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.
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
Part 1: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Tidsram: 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 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.
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
Part 2: Percentage of Participants With HDV Relapse Post End of JNJ-3989 Treatment
Tidsram: 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 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.
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
Parts 1 and 2: Percentage of Participants With Sustained HBV Response Off-treatment Post End of JNJ-3989 Treatment
Tidsram: 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 sustained HBV response off-treatment post end of JNJ-3989 treatment was reported.
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
Part 1: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Tidsram: 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. 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.
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
Part 2: Percentage of Participants With HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Tidsram: 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.
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Janssen Research & Development, LLC

Utredare

  • Studierektor: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

17 september 2020

Primärt slutförande (Faktisk)

19 oktober 2023

Avslutad studie (Faktisk)

5 mars 2025

Studieregistreringsdatum

Först inskickad

28 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

1 september 2020

Första postat (Faktisk)

2 september 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CR108868
  • 2020-001249-37 (EudraCT-nummer)
  • 73763989HPB2004 (Annan identifierare: Janssen Research & Development, LLC)
  • 2023-506763-33-00 (Registeridentifierare: EUCT number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Datadelningspolicyn för Janssen Pharmaceutical Companies of Johnson & Johnson finns på www.janssen.com/clinical-trials/transparency.

Som nämnts på den här webbplatsen kan förfrågningar om åtkomst till studiedata skickas via Yale Open Data Access (YODA) projektwebbplats på yoda.yale.edu

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera