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B型肝炎およびD型肝炎ウイルスに同時感染した参加者におけるJNJ-73763989 + Nucleos(t)Ideアナログの研究 (REEF-D)

2026年6月24日 更新者：Janssen Research & Development, LLC

B型肝炎および肝炎に同時感染した参加者におけるJNJ-73763989 + Nucleos(t)Ideアナログの有効性、安全性、および薬物動態を調査するための延期された実薬治療を伴う第2相、多施設、無作為化、二重盲検、プラセボ対照試験Dウイルス

この研究の目的は、JNJ-73763989 + nucleos(t)ide analog (NA) レジメンの D 型肝炎ウイルス (HDV) に対する治療効果を、NA 単独と比較して評価することです。

調査の概要

状態

完了

条件

介入・治療

詳細な説明

JNJ-73763989 は、リボ核酸干渉メカニズムを介して慢性 B 型肝炎ウイルス (HBV) 感染症を治療するために設計された皮下注射用の肝臓標的抗ウイルス治療薬です。 この第 2 相試験は、HDV に同時感染している HBV 感染患者における JNJ-73763989 の安全性と有効性を評価するように設計されています。 この試験は 2 つのパートで構成されています。パート 1 では JNJ-73763989 + NA の安全性、忍容性、抗ウイルス活性を評価し、パート 2 では HBV/HDV 重複感染の治療における JNJ-73763989 + NA レジメンの安全性と有効性を評価します。 . 各パートには、スクリーニング段階 (4 週間から最大 8 週間まで)、介入段階 (アーム A で 144 週間、アーム B で 148 週間)、フォローアップ段階 (48 週間) の 3 つの段階があります。 個々の研究参加期間は、196 ～ 204 週間です。 安全性と忍容性 (有害事象 [AE] および重篤な AE、臨床検査評価、心電図 [ECG]、バイタルサイン、身体検査を含む)、有効性 (HDV リボ核酸 [RNA]、HBV デオキシリボ核酸 [DNA] および抗原を含む)、および薬物動態は、研究を通して評価されます。

研究の種類

介入

入学 (実際)

52

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

説明

包含基準:

  • 身体診察、病歴、バイタルサイン、スクリーニング時の心電図（ECG）に基づいて医学的に安定
  • -慢性B型肝炎ウイルス（HBV）およびD型肝炎ウイルス（HDV）の重複感染と、スクリーニングの少なくとも6か月前の文書
  • パート1の場合：スクリーニング時のD型肝炎RNA（HDV RNA）が1ミリリットルあたり1000国際単位（IU / mL）以上（> =）。 パート 2 の場合: HDV RNA 値が 500 IU/mL 以上で、B 型肝炎表面抗原 (HBsAg) 値が (
  • アラニンアミノトランスフェラーゼ (ALT) が正常上限 (ULN) を超えているが、10 倍未満 (ULN)
  • 体格指数 (BMI) が 18.0 ～ 35.0 キログラム/平方メートル (kg/m^2) で、極値も含まれる
  • 出産の可能性のある女性の参加者、または出産の可能性のある女性のパートナーとの男性の参加者のために、非常に効果的な避妊手段が実施されている
  • -非肝硬変の参加者およびスクリーニング時の代償性肝硬変（Child PughクラスA）の参加者（パート1）および参加者は、パート2への登録のために肝硬変およびデシリットルあたり140,000以上の血小板数（dL）でなければなりません

除外基準:

  • -A型、C型、またはE型肝炎ウイルス感染による感染の証拠、またはスクリーニング時のヒト免疫不全、ウイルス1型（HIV-1）またはHIV-2感染の証拠
  • -肝代償不全の臨床徴候/症状の病歴または証拠（以下を含むがこれらに限定されない）：門脈圧亢進症、腹水、肝性脳症、食道静脈瘤、またはプロトコルで定義されている肝機能の低下を示す検査異常
  • 非 HBV/HDV 病因の肝疾患の証拠
  • 肝細胞がん（HCC）の徴候
  • -スクリーニング時のプロトコルで定義されている重大な検査室異常
  • -スクリーニング前の5年以内に悪性腫瘍の病歴を持つ参加者
  • -プロトコルで定義されているスクリーニング時の異常な洞調律またはECGパラメーター
  • -過去または現在の心不整脈、または重大または不安定な心疾患の病歴または臨床的証拠
  • -研究者および/またはスポンサーの意見では、参加が参加者の最善の利益にならない、現在または以前の病気のある参加者
  • -臨床的に重要な皮膚疾患または薬物発疹の病歴または現在
  • -JNJ-3989またはその賦形剤またはプラセボ成分の賦形剤に対する既知のアレルギー、過敏症、または不耐性のある参加者
  • エンテカビル（ETV）、テノホビル ジソプロキシル、またはテノホビル アラフェナミド（TAF）の使用に対する現地の処方情報による禁忌
  • -プロトコルごとに許可されていない治療を受けた参加者
  • -妊娠中、授乳中、または妊娠を計画している女性参加者 この研究に登録されている間、または研究介入の最後の投与後90日以内
  • 在籍中に子供をもうける予定の男性参加者
  • -大手術を受けた、または計画した参加者（全身麻酔が必要な場合など）、または臓器移植を受けた参加者
  • 脆弱な参加者 (例: 投獄されている個人、法的保護措置を受けている個人)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：即時アクティブ治療アーム: JNJ-73763989 + NA
参加者は、NA（エンテカビル [ETV]、テノホビル ジソプロキシル、またはテノホビル アラフェナミド [TAF]）とともに 4 週間ごと（Q4W）に JNJ-73763989 皮下（SC）注射を 1 日 1 回、パート 1 では 144 週間、少なくとも 96 週間投与されます。パート 2 で。
薬：テノホビルジソプロキシル
テノホビルジソプロキシルフィルムコーティング錠は経口投与されます。
薬：JNJ-73763989
JNJ-73763989はSC注射として投与されます。
他の名前：
  • JNJ-3989
薬：エンテカビル（ETV）一水和物
ETV一水和物フィルムコーティング錠は経口投与されます。
薬：テノホビル アラフェナミド (TAF)
TAFフィルムコーティング錠は経口投与します。
プラセボコンパレーター：遅延有効治療群: プラセボ+NA+JNJ-73763989+NA
参加者は、JNJ-73763989 SC 注射 Q4W と NA (ETV、テノホビル ジソプロキシル、または TAF) に一致するプラセボを 52 週間 1 日 1 回投与され、その後パート 1 では NA とともに JNJ-73763989 SC 注射 Q4W を 96 週間にわたって 1 日 1 回投与されます。パート 2 では少なくとも 48 週間。
薬：テノホビルジソプロキシル
テノホビルジソプロキシルフィルムコーティング錠は経口投与されます。
薬：JNJ-73763989
JNJ-73763989はSC注射として投与されます。
他の名前：
  • JNJ-3989
薬：エンテカビル（ETV）一水和物
ETV一水和物フィルムコーティング錠は経口投与されます。
薬：テノホビル アラフェナミド (TAF)
TAFフィルムコーティング錠は経口投与します。
薬：プラセボ
JNJ-73763989に一致するプラセボは、SC注射として投与されます。

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
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)
時間枠：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)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Janssen Research & Development, LLC

捜査官

  • スタディディレクター：Janssen Research & Development, LLC Clinical Trial、Janssen Research & Development, LLC

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年9月17日

一次修了 (実際)

2023年10月19日

研究の完了 (実際)

2025年3月5日

試験登録日

最初に提出

2020年8月28日

QC基準を満たした最初の提出物

2020年9月1日

最初の投稿 (実際)

2020年9月2日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月22日

QC基準を満たした最後の更新が送信されました

2026年6月24日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • CR108868
  • 2020-001249-37 (EudraCT番号)
  • 73763989HPB2004 (その他の識別子：Janssen Research & Development, LLC)
  • 2023-506763-33-00 (レジストリ識別子：EUCT number)

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はい

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米国FDA規制医薬品の研究

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米国FDA規制機器製品の研究

いいえ

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テノホビルジソプロキシルの臨床試験

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