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Antiviral
Combination Therapy for Chronic Hepatitis B
Phase 2
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently not treated chronic hepatitis B virus (HBV) infection with alanine transaminase (ALT) less than (<) 2* upper limit of normal (ULN) at screening and HBV deoxyribonucleic acid (DNA) greater than or equal to (>=) 20,000 international units per milliliter (IU/mL)
Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than or equal to (<=) 9 Kilopascal (kPa) at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 253 postdose
Awards & highlights
Study Summary
This trial is testing a new combination treatment for hepatitis C.
Who is the study for?
This trial is for adults with chronic Hepatitis B who haven't been treated yet. They should have mild to moderate liver scarring, stable health, normal heart readings, and a specific range of liver enzyme levels and body weight. People with other hepatitis viruses, HIV, recent cancer history or signs of advanced liver disease can't join.Check my eligibility
What is being tested?
The study tests the effectiveness of JNJ-73763989 combined with PegIFN-alpha-2a and an antiviral drug (NA) in treating Hepatitis B. It may also explore adding another drug called JNJ-56136379 to this combination.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from PegIFN-alpha-2a or JNJ drugs, flu-like symptoms, changes in blood counts or mood swings. The antiviral drugs might cause kidney issues, bone pain or decrease bone density.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have chronic hepatitis B with specific blood test levels.
Select...
My liver fibrosis is mild or moderate.
Select...
My recent health checks show that my condition is stable.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 253 postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 253 postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance 24 Weeks After Stopping all Study Interventions of Consolidation Phase and Without Restarting NA Treatment
Secondary outcome measures
Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 hours)]
Change from Baseline in Hepatitis B Surface Antigen (HBsAg)
Change from Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels
+22 moreSide effects data
From 2024 Phase 2 trial • 24 Patients • NCT0458578930%
Headache
20%
Fatigue
20%
Vomiting
20%
Oropharyngeal Pain
20%
Eczema
20%
Abdominal Pain Lower
20%
Dizziness
10%
Myalgia
10%
Alanine Aminotransferase Increased
10%
Injection Site Erythema
10%
Asthenia
10%
Renal Tubular Disorder
10%
Diarrhoea
10%
Anaemia
10%
Alopecia
10%
Gastritis
10%
Abdominal Pain Upper
10%
Amylase Increased
10%
Chills
10%
Musculoskeletal Chest Pain
10%
Neck Pain
10%
Nasal Congestion
10%
Groin Pain
10%
Mood Swings
10%
Rhinorrhoea
10%
Pruritus
10%
Gastroenteritis
10%
Abdominal Pain
10%
Abdominal Discomfort
10%
Gastrointestinal Sounds Abnormal
10%
Hypoaesthesia Oral
10%
Tinea Versicolour
10%
Injection Site Pain
10%
Injection Site Reaction
10%
Pyrexia
10%
Covid-19
10%
Upper Respiratory Tract Infection
10%
Weight Decreased
10%
Rash Macular
10%
Pain in Extremity
10%
Vaginal Haemorrhage
10%
Cough
10%
Rash Maculo-Papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panel 1
Panel 2
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Participants Enrolled After Protocol Amendment 5 is in EffectExperimental Treatment3 Interventions
Following implementation of protocol amendment- 5 and 6, all participants will receive JNJ-73763989 subcutaneously along with NA (tenofovir disoproxil tablets orally) for 36 weeks (induction phase). In the consolidation phase, participants will receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and NA for 12 weeks. According to predefined criteria NA treatment may be continued during the follow up (FU) phase. JNJ-56136379 (JNJ-6379) was discontinued as per amendment 6 of the study.
Group II: Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in EffectExperimental Treatment5 Interventions
During the Induction phase, participants will receive JNJ-73763989 subcutaneously along with JNJ-56136379 tablet orally with NA (either tenofovir disoproxil or tenofovir alafenamide tablets orally) treatment. At the start of consolidation phase, participants will be randomized to receive PegIFN-alpha-2a subcutaneously in addition to JNJ-73763989 and JNJ-56136379 with NA in arm 1 and arm 2 (without PegIFN-alpha-2a). According to predefined criteria NA treatment may be continued during the follow up (FU) phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-73763989
2021
Completed Phase 2
~820
JNJ-56136379
2017
Completed Phase 2
~1080
PegIFN-alpha-2a
2020
Completed Phase 2
~60
Tenofovir disoproxil
2016
Completed Phase 3
~3910
Tenofovir alafenamide
2002
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,254 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,851 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot use PegIFN-α2a due to health reasons.I have chronic hepatitis B with specific blood test levels.I have no signs of severe liver problems like swelling, confusion, or internal bleeding.I have had cancer within the last 5 years.My liver disease is not caused by hepatitis B.I have had or am planning to have major surgery or received an organ transplant.My liver fibrosis is mild or moderate.My recent health checks show that my condition is stable.Your body weight is within the range of 18 to 35 kilograms per square meter, including both ends.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: Participants Enrolled Prior to Protocol Amendment 5 is in Effect
- Group 2: Cohort 2: Participants Enrolled After Protocol Amendment 5 is in Effect
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial available to adults over the age of 20?
"Eligibility for this study requires that participants are between 18-55 years old."
Answered by AI
Are we currently recruiting for this research project?
"This study is no longer recruiting patients for participation. According to the information available on clinicaltrials.gov, this trial was posted on September 14th 2020 and updated October 25th 2020. If you are interested in other studies, there are 294 trials actively recruiting patients with hepatitis b, chronic and 122 studies for JNJ-73763989 that are currently seeking participants."
Answered by AI
What is the regulatory status of JNJ-73763989?
"JNJ-73763989 has not been proven effective in any capacity, but there is some evidence that suggests it may be safe. Our team rates its safety at a 2."
Answered by AI
To whom does this study give the opportunity to participate?
"This study is testing a new treatment for hepatitis b, and thus requires participants that have the chronic form of the virus. A total of 54 patients between 18-55 years old are being enrolled nationwide."
Answered by AI
What are the conventional indications for JNJ-73763989?
"JNJ-73763989 is most commonly used to treat patients that have supressed the virus for 3 months. Additionally, it is an approved medication to treat conditions such as tenofovir and treatment failure in high risk patients."
Answered by AI
How many people are allowed to join this clinical trial?
"As of October 25th, 2022, this study is no longer actively recruiting patients. It was initially posted on September 14th, 2020. If you are looking for other medical studies to participate in, there are 294 trials currently underway for participants with hepatitis b and 122 for JNJ-73763989."
Answered by AI
Are there other research papers that mention JNJ-73763989?
"JNJ-73763989 was first studied in the year 2002 at University of Zurich. Since then there have been 411 completed trials. There are presently 122 live clinical trials, with many of these trials based in Pittsburgh, Pennsylvania."
Answered by AI
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