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Studie JNJ-73763989 + analog Nucleos(t)Ide u účastníků koinfikovaných virem hepatitidy B a hepatitidy D (REEF-D)

24. června 2026 aktualizováno: Janssen Research & Development, LLC

Fáze 2, multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie s odloženou aktivní léčbou ke zkoumání účinnosti, bezpečnosti a farmakokinetiky JNJ-73763989 + analog Nucleos(t)Ide u účastníků koinfikovaných hepatitidou B a hepatitidou D virus

Účelem studie je vyhodnotit účinnost při léčbě proti viru hepatitidy D (HDV) režimu JNJ-73763989 + nukleos(t)idový analog (NA) ve srovnání se samotnou NA.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

JNJ-73763989 je antivirové léčivo cílené na játra pro subkutánní injekci určené k léčbě chronické infekce virem hepatitidy B (HBV) prostřednictvím mechanismu interference ribonukleové kyseliny. Tato studie fáze 2 je navržena tak, aby vyhodnotila bezpečnost a účinnost JNJ-73763989 u pacientů infikovaných HBV, kteří jsou současně infikováni HDV. Studie se skládá ze 2 částí: Část 1 bude hodnotit bezpečnost, snášenlivost a antivirovou aktivitu JNJ-73763989 + NA, zatímco část 2 bude hodnotit bezpečnost a účinnost režimu JNJ-73763989 + NA při léčbě koinfekce HBV/HDV . Každá část obsahuje 3 fáze: Screeningová fáze (od 4 týdnů do maximálně 8 týdnů), Intervenční fáze (144 týdnů pro rameno A a 148 týdnů pro rameno B) a Fáze sledování (48 týdnů). Délka individuální studijní účasti se bude pohybovat mezi 196 a 204 týdny. Bezpečnost a snášenlivost (včetně nežádoucích účinků [AE] a závažných AE, laboratorních vyšetření, elektrokardiogramu [EKG], vitálních funkcí, fyzikálního vyšetření), účinnosti (včetně HDV ribonukleové kyseliny [RNA], HBV deoxyribonukleové kyseliny [DNA] a antigenů) a farmakokinetika bude hodnocena v průběhu studie.

Typ studie

Intervenční

Zápis (Aktuální)

52

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Lékařsky stabilní na základě fyzikálního vyšetření, anamnézy, vitálních funkcí, elektrokardiogramu (EKG) při screeningu
  • Souběžná infekce chronickou hepatitidou B (HBV) a virem hepatitidy D (HDV) s dokumentací alespoň 6 měsíců před screeningem
  • Pro část 1: RNA hepatitidy D (HDV RNA) větší nebo rovna (>=) 1000 mezinárodních jednotek na mililitr (IU/ml) při screeningu. Pro část 2: musí mít hodnoty HDV RNA >= 500 IU/ml a musí mít hodnoty povrchového antigenu hepatitidy B (HBsAg) menší nebo rovné (
  • Alaninaminotransferáza (ALT) vyšší než horní limit normy (ULN), ale méně než 10krát (ULN)
  • Index tělesné hmotnosti (BMI) mezi 18,0 a 35,0 kilogramy na metr čtvereční (kg/m^2), včetně extrémů
  • Vysoce účinná antikoncepční opatření pro ženy ve fertilním věku nebo mužské účastníky s partnerkami ve fertilním věku
  • Účastníci bez cirhózy a účastníci s kompenzovanou cirhózou (Child Pugh třída A) při screeningu (část 1) a účastníci musí mít nepřítomnost cirhózy a počet krevních destiček >= 140 000 na decilitr (dL), aby se mohli zapsat do části 2

Kritéria vyloučení:

  • Důkaz infekce virem hepatitidy A, C nebo E nebo důkaz lidské imunodeficience, infekce virem typu 1 (HIV-1) nebo HIV-2 při screeningu
  • Anamnéza nebo známky klinických příznaků/příznaků jaterní dekompenzace včetně, ale bez omezení na: portální hypertenze, ascites, jaterní encefalopatie, jícnové varixy nebo jakékoli laboratorní abnormality naznačující sníženou funkci jater, jak je definováno v protokolu
  • Důkaz jaterního onemocnění non-HBV/HDV etiologie
  • Příznaky hepatocelulárního karcinomu (HCC)
  • Významné laboratorní abnormality definované v protokolu při screeningu
  • Účastníci s anamnézou malignity do 5 let před screeningem
  • Abnormální sinusový rytmus nebo parametry EKG při screeningu, jak je definováno v protokolu
  • Anamnéza nebo současná srdeční arytmie nebo anamnéza nebo klinický důkaz významného nebo nestabilního srdečního onemocnění
  • Účastníci s jakýmkoli současným nebo předchozím onemocněním, pro které by podle názoru zkoušejícího a/nebo sponzora nebyla účast v nejlepším zájmu účastníka
  • Anamnéza nebo současné klinicky významné kožní onemocnění nebo léková vyrážka
  • Účastníci se známými alergiemi, přecitlivělostí nebo intolerancí na JNJ-3989 nebo jeho pomocné látky nebo pomocné látky s obsahem placeba
  • Kontraindikace použití entekaviru (ETV), tenofovir-disoproxilu nebo tenofovir-alafenamidu (TAF) podle místních informací o předepisování
  • Účastníci, kteří podstoupili jakékoli terapie zakázané podle protokolu
  • Účastnice, které jsou těhotné, kojí nebo plánují otěhotnět, zatímco jsou zařazeny do této studie nebo do 90 dnů po poslední dávce studijní intervence
  • Mužští účastníci, kteří plánují zplodit dítě během zápisu
  • Účastníci, kteří podstoupili nebo plánovali velký chirurgický zákrok (například vyžadující celkovou anestezii) nebo kteří podstoupili transplantaci orgánu
  • Zranitelní účastníci (například uvěznění jednotlivci, jednotlivci pod opatřením právní ochrany)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Rameno s okamžitou aktivní léčbou: JNJ-73763989 + NA
Účastníci dostanou subkutánní (SC) injekci JNJ-73763989 každé 4 týdny (Q4W) spolu s NA (entekavir [ETV], tenofovir disoproxil nebo tenofovir alafenamid [TAF]) jednou denně po dobu 144 týdnů v části 1 a po dobu alespoň 96 týdnů v části 2.
Lék: Tenofovir disoproxil
Tenofovir disoproxil potahovaná tableta bude podávána perorálně.
Lék: JNJ-73763989
JNJ-73763989 bude podáván jako SC injekce.
Ostatní jména:
  • JNJ-3989
Lék: Entekavir (ETV) monohydrát
ETV monohydrát potahovaná tableta bude podávána perorálně.
Lék: Tenofovir alafenamid (TAF)
Potahovaná tableta TAF bude podávána perorálně.
Komparátor placeba: Rameno odložené aktivní léčby: Placebo+NA+JNJ-73763989+NA
Účastníci dostanou odpovídající placebo k injekci JNJ-73763989 SC Q4W spolu s NA (ETV, tenofovir disoproxil nebo TAF) jednou denně po dobu 52 týdnů, po které bude následovat SC injekce JNJ-73763989 Q4W spolu s NA jednou denně po dobu 96 týdnů v části 1 a po dobu alespoň 48 týdnů v části 2.
Lék: Tenofovir disoproxil
Tenofovir disoproxil potahovaná tableta bude podávána perorálně.
Lék: JNJ-73763989
JNJ-73763989 bude podáván jako SC injekce.
Ostatní jména:
  • JNJ-3989
Lék: Entekavir (ETV) monohydrát
ETV monohydrát potahovaná tableta bude podávána perorálně.
Lék: Tenofovir alafenamid (TAF)
Potahovaná tableta TAF bude podávána perorálně.
Lék: Placebo
Odpovídající placebo k JNJ-73763989 bude podáváno jako SC injekce.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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)
Časové okno: 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)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Janssen Research & Development, LLC

Vyšetřovatelé

  • Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. září 2020

Primární dokončení (Aktuální)

19. října 2023

Dokončení studie (Aktuální)

5. března 2025

Termíny zápisu do studia

První předloženo

28. srpna 2020

První předloženo, které splnilo kritéria kontroly kvality

1. září 2020

První zveřejněno (Aktuální)

2. září 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

24. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CR108868
  • 2020-001249-37 (Číslo EudraCT)
  • 73763989HPB2004 (Jiný identifikátor: Janssen Research & Development, LLC)
  • 2023-506763-33-00 (Identifikátor registru: EUCT number)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Zásady sdílení dat Janssen Pharmaceutical Companies of Johnson & Johnson jsou k dispozici na www.janssen.com/clinical-trials/transparency.

Jak je uvedeno na této stránce, žádosti o přístup k datům studie lze podávat prostřednictvím stránky projektu Yale Open Data Access (YODA) na adrese yoda.yale.edu

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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