A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (REEF-D)

April 24, 2025 updated by: Janssen Research & Development, LLC

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via ribonucleic acid interference mechanism. This phase 2 study is designed to evaluate safety and efficacy of JNJ-73763989 in HBV infected patients who are co-infected with HDV. The study consists of 2 parts: Part 1 will evaluate safety, tolerability and antiviral activity of JNJ-73763989 + NA while Part 2 will evaluate the safety and efficacy of the JNJ-73763989 + NA regimen in the treatment of HBV/HDV co-infection. Each part includes 3 phases: Screening phase (from 4 Week up to maximum of 8 weeks), Intervention phase (144 Week for Arm A and 148 Week for Arm B) and Follow-up phase (48 Week). The duration of individual study participation will be between 196 and 204 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HDV ribonucleic acid [RNA], HBV deoxyribonucleic acid [DNA] and antigens) , and pharmacokinetics will be assessed throughout the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
  • Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
  • For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values >= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (<=) 10000 IU/mL at screening or HDV RNA values at screening are <= 100000 IU/mL
  • Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
  • Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
  • Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
  • Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of >= 140000 per deciliter (dL) for enrollment into Part-2

Exclusion Criteria:

  • Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
  • History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
  • Evidence of liver disease of non-HBV/HDV etiology
  • Signs of hepatocellular carcinoma (HCC)
  • Significant laboratory abnormalities as defined in the protocol at screening
  • Participants with a history of malignancy within 5 years before screening
  • Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
  • History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
  • Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
  • History of or current clinically significant skin disease or drug rash
  • Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content
  • Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
  • Participants who have taken any therapies disallowed per protocol
  • Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
  • Male participants who plan to father a child while enrolled
  • Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
  • Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Active Treatment arm: JNJ-73763989 + NA
Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV], tenofovir disoproxil, or tenofovir alafenamide [TAF]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.
Drug: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
Drug: JNJ-73763989
JNJ-73763989 will be administered as a SC injection.
Other Names:
  • JNJ-3989
Drug: Entecavir (ETV) monohydrate
ETV monohydrate film coated tablet will be administered orally.
Drug: Tenofovir alafenamide (TAF)
TAF film coated tablet will be administered orally.
Placebo Comparator: Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA
Participants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.
Drug: Tenofovir disoproxil
Tenofovir disoproxil film-coated tablet will be administered orally.
Drug: JNJ-73763989
JNJ-73763989 will be administered as a SC injection.
Other Names:
  • JNJ-3989
Drug: Entecavir (ETV) monohydrate
ETV monohydrate film coated tablet will be administered orally.
Drug: Tenofovir alafenamide (TAF)
TAF film coated tablet will be administered orally.
Drug: Placebo
Matching placebo to JNJ-73763989 will be administered as a SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Time Frame: At Week 48
Percentage of participants with 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. Target not detected (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.
At 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 ALT at Week 48 (Multiple Imputation Approach)
Time Frame: At 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.
At Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND at Week 48
Time Frame: Week 48
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND at Week 48 will be reported.
Week 48
Percentage of Participants With Normal ALT at Week 48
Time Frame: Week 48
Percentage of participants with normal ALT at Week 48 will be reported.
Week 48
Percentage of Participants with HBsAg Seroclearance at Week 48
Time Frame: Week 48
Percentage of participants with hepatitis B s antigen (HBsAg) seroclearance at Week 48 will be reported.
Week 48
Percentage of Participants with >=2 kPa Reduction From Baseline in LSM assessed by VCTE (FibroScan) at Week 48
Time Frame: Week 48
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 will be reported.
Week 48
Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT
Time Frame: Baseline up to Week 196
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND in combination with normal ALT will be reported.
Baseline up to Week 196
Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination with Normal ALT
Time Frame: Up to Week 196
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline in combination with normal ALT will be reported.
Up to Week 196
Percentage of Participants with HDV RNA TND in Combination with Normal ALT
Time Frame: Up to Week 196
Percentage of participants with HDV RNA TND in combination with normal ALT will be reported.
Up to Week 196
Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
Time Frame: Up to Week 196
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline or HDV RNA TND will be reported.
Up to Week 196
Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline
Time Frame: Up to Week 196
Percentage of participants with HDV RNA >=2 log10 IU/mL decline from baseline will be reported.
Up to Week 196
Percentage of Participants with HDV RNA TND
Time Frame: Up to Week 196
Percentage of participants with HDV RNA TND will be reported.
Up to Week 196
Percentage of Participants with Normal ALT
Time Frame: Up to Week 196
Percentage of participants with normal ALT will be reported.
Up to Week 196
Time to Reach HDV RNA >=2 log10 IU/mL Decline or HDV RNA TND
Time Frame: Up to Week 196
Time to reach HDV RNA >=2 log10 IU/mL decline or HDV RNA TND will be reported.
Up to Week 196
Change from Baseline in HDV RNA
Time Frame: Baseline and up to Week 196
Change from baseline in HDV RNA will be reported.
Baseline and up to Week 196
Changes from Baseline in ALT
Time Frame: Baseline and up to Week 196
Changes from baseline in ALT will be reported.
Baseline and up to Week 196
Percentage of Participants with Adverse Events (AEs) and Serious AEs
Time Frame: From screening up to Week 196
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A 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.
From screening up to Week 196
Percentage of Participants with Abnormalities in Laboratory Parameters
Time Frame: From screening up to Week 196
Percentage of participants with abnormalities in laboratory parameters (hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, and renal biomarkers) will be reported.
From screening up to Week 196
Percentage of Participants with Abnormalities in 12-lead Electrocardiogram (ECGs)
Time Frame: From screening up to Week 196
Percentage of participants with abnormalities in 12-lead electrocardiogram (ECGs) will be reported.
From screening up to Week 196
Percentage of Participants with Abnormalities in Vital Signs
Time Frame: From screening up to Week 196
Percentage of participants with abnormalities in vital signs (systolic and diastolic blood pressure, pulse rate, and body temperature) will be reported.
From screening up to Week 196
Percentage of Participants with Abnormalities in Physical Examination
Time Frame: From screening up to Week 196
Percentage of participants with abnormalities in physical examination will be reported.
From screening up to Week 196
Percentage of Participants with HBsAg Seroclearance and/or Seroconversion
Time Frame: Up to Week 196
Percentage of participants with HBsAg seroclearance and/or seroconversion will be reported.
Up to Week 196
Change from Baseline Over Time in HBsAg
Time Frame: Baseline and up to Week 196
Change from baseline over time in HBsAg will be reported.
Baseline and up to Week 196
Change from Baseline Over Time in HBeAg
Time Frame: Baseline and up to Week 196
Change from baseline over time in HBeAg will be reported.
Baseline and up to Week 196
Change from Baseline Over Time in HBV DNA
Time Frame: Baseline and up to Week 196
Change from baseline over time in HBV DNA will be reported.
Baseline and up to Week 196
Percentage of Participants with HBsAg levels below/above different cut-offs
Time Frame: Up to Week 196
Percentage of participants with HBsAg levels below/above different cut-offs will be reported.
Up to Week 196
Percentage of Participants with HBeAg levels below/above different cut-offs
Time Frame: Up to Week 196
Percentage of participants with HBeAg levels below/above different cut-offs will be reported.
Up to Week 196
Percentage of Participants with HBV DNA levels below/above different cut-offs
Time Frame: Up to Week 196
Percentage of participants with HBV DNA levels below/above different cut-offs will be reported.
Up to Week 196
Percentage of Participants with HBsAg Change From Baseline Below/Above Different Cut-offs
Time Frame: Baseline and up to Week 196
Percentage of participants with HBsAg change from baseline below/above different cut-offs will be reported.
Baseline and up to Week 196
Percentage of Participants with HBeAg Change From Baseline Below/Above Different Cut-offs
Time Frame: Baseline and up to Week 196
Percentage of participants with HBeAg change from baseline below/above different cut-offs will be reported.
Baseline and up to Week 196
Percentage of Participants with HBV DNA Change From Baseline Below/Above Different Cut-offs
Time Frame: Baseline and up to Week 196
Percentage of participants with HBV DNA change from baseline below/above different cut-offs will be reported.
Baseline and up to Week 196
Time to Reach Efficacy Thresholds such as HBsAg <1 IU/mL
Time Frame: Up to Week 196
Time to reach efficacy thresholds such as HBsAg <1 IU/mL will be reported.
Up to Week 196
Percentage of Participants with HBV DNA Virologic Breakthrough
Time Frame: Up to Week 196
Percentage of participants with virologic breakthrough (defined as confirmed on-treatment HBV DNA increase by greater than [>] 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below < lower limit of quantification [LLOQ] of the HBV DNA assay) will be reported.
Up to Week 196
Percentage of Participants with >=2 kPa Reduction from Baseline in LSM Assessed by VCTE (FibroScan)
Time Frame: Up to Week 196
Percentage of participants with >=2 kPa reduction from baseline in LSM assessed by VCTE (FibroScan) will be reported.
Up to Week 196
Change from Baseline in LSM Over Time Assessed by VCTE (FibroScan)
Time Frame: Baseline and up to Week 196
Change from baseline in LSM over time assessed by VCTE (FibroScan) will be reported.
Baseline and up to Week 196
Percentage of Participants with Sustained HDV Response Off-treatment Post end of JNJ-73763989 Treatment
Time Frame: Up to Week 196
Percentage of participants with sustained HDV response off-treatment post end of JNJ-73763989 treatment will be reported.
Up to Week 196
Percentage of Participants with HDV Relapse Post End of JNJ 73763989 Treatment
Time Frame: Up to Week 196
Percentage of participants with HDV relapse post end of JNJ 73763989 treatment will be reported.
Up to Week 196
Percentage of Participants with Sustained HBV Response Off-Treatment Post End of JNJ-73763989 Treatment.
Time Frame: Up to Week 196
Percentage of participants with sustained HBV response off-treatment post end of JNJ-73763989 treatment will be reported.
Up to Week 196
Percentage of Participants with HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
Time Frame: Up to Week 196
Percentage of participants with HBV flare (virologic, biochemical, and clinical) post end of treatment will be reported.
Up to Week 196

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108868
  • 2020-001249-37 (EudraCT Number)
  • 73763989HPB2004 (Other Identifier: Janssen Research & Development, LLC)
  • 2023-506763-33-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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