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B형 간염 및 D형 간염 바이러스에 공동 감염된 참가자의 JNJ-73763989 + Nucleos(t)Ide 유사체 연구 (REEF-D)

2026년 6월 24일 업데이트: Janssen Research & Development, LLC

B형 간염 및 간염에 동시 감염된 참가자에서 JNJ-73763989 + Nucleos(t)Ide 유사체의 효능, 안전성 및 약동학을 조사하기 위한 지연 활성 치료를 통한 2상, 다기관, 무작위, 이중 맹검, 위약 대조 연구 D 바이러스

이 연구의 목적은 NA 단독과 비교하여 JNJ-73763989 + 뉴클레오사이드 유사체(NA) 요법의 D형 간염 바이러스(HDV)에 대한 치료 중 효능을 평가하는 것입니다.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

JNJ-73763989는 리보핵산 간섭 메커니즘을 통해 만성 B형 간염 바이러스(HBV) 감염을 치료하도록 설계된 피하주사용 간 표적 항바이러스 치료제다. 이 2상 연구는 HDV에 동시 감염된 HBV 감염 환자에서 JNJ-73763989의 안전성과 효능을 평가하도록 설계되었습니다. 이 연구는 두 부분으로 구성됩니다. 1부는 JNJ-73763989 + NA의 안전성, 내약성 및 항바이러스 활성을 평가하고 2부는 HBV/HDV 동시 감염 치료에서 JNJ-73763989 + NA 요법의 안전성과 효능을 평가합니다. . 각 부분에는 선별 단계(4주에서 최대 8주), 개입 단계(A군 144주, B군 148주) 및 추적 단계(48주)의 3단계가 포함됩니다. 개별 연구 참여 기간은 196주에서 204주 사이입니다. 안전성 및 내약성(부작용[AE] 및 심각한 AE, 실험실 평가, 심전도[ECG], 활력 징후, 신체 검사 포함), 효능(HDV 리보핵산[RNA], HBV 데옥시리보핵산[DNA] 및 항원 포함) 및 약동학은 연구 전반에 걸쳐 평가될 것이다.

연구 유형

중재적

등록 (실제)

52

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 스크리닝 시 신체 검사, 병력, 활력 징후, 심전도(ECG)에 근거하여 의학적으로 안정적임
  • 만성 B형 간염 바이러스(HBV) 및 D형 간염 바이러스(HDV) 동시 감염, 스크리닝 최소 6개월 전에 문서화
  • 파트 1의 경우: D형 간염 RNA(HDV RNA)가 스크리닝 시 1000 IU/mL 이상(>=)입니다. 파트 2의 경우: HDV RNA 값 >= 500 IU/mL이어야 하며 B형 간염 표면 항원(HBsAg) 값이 (
  • 알라닌 아미노트랜스퍼라제(ALT)가 정상 상한(ULN)보다 크지만 10배 미만(ULN)
  • 체질량지수(BMI) 18.0 ~ 35.0kg/m²(kg/m^2), 극단값 포함
  • 가임 여성 참가자 또는 가임 여성 파트너가 있는 남성 참가자를 위한 매우 효과적인 피임 조치
  • 간경변이 없는 참가자 및 대상성 간경변증(Child Pugh 클래스 A)이 있는 참가자는 스크리닝(1부)에서 참가자는 간경변증이 없고 2부 등록을 위해 데시리터(dL)당 혈소판 수가 >= 140,000이어야 합니다.

제외 기준:

  • 스크리닝 시 A, C 또는 E형 간염 바이러스 감염의 증거 또는 인간 면역결핍, 바이러스 1형(HIV-1) 또는 HIV-2 감염의 증거
  • 문맥 고혈압, 복수, 간성 뇌병증, 식도 정맥류 또는 프로토콜에 정의된 간 기능 감소를 나타내는 실험실 이상을 포함하되 이에 국한되지 않는 간 대상부전의 임상 징후/증상의 병력 또는 증거
  • 비 HBV/HDV 병인의 간 질환 증거
  • 간세포 암종(HCC)의 징후
  • 스크리닝 시 프로토콜에 정의된 중대한 검사실 이상
  • 스크리닝 전 5년 이내 악성 종양 병력이 있는 참가자
  • 프로토콜에 정의된 대로 스크리닝 시 비정상 동리듬 또는 ECG 매개변수
  • 심부정맥의 병력 또는 현재, 중요하거나 불안정한 심장 질환의 병력 또는 임상적 증거
  • 조사자 및/또는 후원자의 의견에 따라 참여가 참여자에게 최선의 이익이 되지 않을 현재 또는 이전 질병이 있는 참여자
  • 임상적으로 중요한 피부 질환 또는 약물 발진의 병력 또는 현재
  • JNJ-3989 또는 그 부형제 또는 위약 내용물의 부형제에 대해 알려진 알레르기, 과민성 또는 과민증이 있는 참가자
  • 현지 처방 정보에 따른 엔테카비르(ETV), 테노포비르 디소프록실 또는 테노포비르 알라페나미드(TAF) 사용에 대한 금기
  • 프로토콜에 따라 허용되지 않는 치료를 받은 참가자
  • 임신 중이거나 모유 수유 중이거나 본 연구에 등록하는 동안 또는 연구 개입의 마지막 투여 후 90일 이내에 임신할 계획이 있는 여성 참가자
  • 등록하는 동안 아이의 아버지가 될 계획인 남성 참가자
  • 대수술(예: 전신 마취 필요)을 받았거나 계획한 참가자 또는 장기 이식을 받은 참가자
  • 취약한 참여자(예: 수감자, 법적 보호 조치를 받는 개인)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 즉시 활성 치료군: JNJ-73763989 + NA
참가자는 파트 1에서 144주 동안 그리고 최소 96주 동안 NA(엔테카비르[ETV], 테노포비르 디소프록실 또는 테노포비르 알라페나미드[TAF])와 함께 4주마다(Q4W) JNJ-73763989 피하(SC) 주사를 1일 1회 투여받게 됩니다. 2부에서.
의약품: 테노포비르 디소프록실
Tenofovir disoproxil 필름 코팅 정제는 경구로 투여됩니다.
의약품: JNJ-73763989
JNJ-73763989는 SC 주사로 투여됩니다.
다른 이름들:
  • JNJ-3989
의약품: 엔테카비르(ETV) 일수화물
ETV 일수화물 필름코팅정은 경구 투여한다.
의약품: 테노포비르 알라페나미드(TAF)
TAF 필름 코팅 정제는 경구 투여됩니다.
위약 비교기: 지연된 활성 치료군: 위약+NA+JNJ-73763989+NA
참가자는 52주 동안 1일 1회 JNJ-73763989 SC 주사 Q4W와 NA(ETV, 테노포비르 디소프록실 또는 TAF)에 상응하는 위약을 투여받은 후 파트 1에서 96주 동안 1일 1회 JNJ-73763989 SC 주사 Q4W와 NA를 투여받게 됩니다. 파트 2에서는 최소 48주.
의약품: 테노포비르 디소프록실
Tenofovir disoproxil 필름 코팅 정제는 경구로 투여됩니다.
의약품: JNJ-73763989
JNJ-73763989는 SC 주사로 투여됩니다.
다른 이름들:
  • JNJ-3989
의약품: 엔테카비르(ETV) 일수화물
ETV 일수화물 필름코팅정은 경구 투여한다.
의약품: 테노포비르 알라페나미드(TAF)
TAF 필름 코팅 정제는 경구 투여됩니다.
의약품: 위약
JNJ-73763989에 일치하는 위약이 SC 주사로 투여됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
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)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Research & Development, LLC

수사관

  • 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 9월 17일

기본 완료 (실제)

2023년 10월 19일

연구 완료 (실제)

2025년 3월 5일

연구 등록 날짜

최초 제출

2020년 8월 28일

QC 기준을 충족하는 최초 제출

2020년 9월 1일

처음 게시됨 (실제)

2020년 9월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 24일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CR108868
  • 2020-001249-37 (EudraCT 번호)
  • 73763989HPB2004 (기타 식별자: Janssen Research & Development, LLC)
  • 2023-506763-33-00 (레지스트리 식별자: EUCT number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Johnson & Johnson의 Janssen 제약 회사의 데이터 공유 정책은 www.janssen.com/clinical-trials/transparency에서 확인할 수 있습니다.

이 사이트에 명시된 바와 같이 연구 데이터에 대한 액세스 요청은 Yale Open Data Access(YODA) 프로젝트 사이트(yoda.yale.edu)를 통해 제출할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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구독하다