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Virus Therapy

JNJ-3989 Combination Therapy for Chronic Hepatitis B (INSIGHT Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up panel 1 and 2: post-dose on days 1, 29, 85, 169, 337
Awards & highlights

INSIGHT Trial Summary

This trial will study how well JNJ-3989-based combination treatment works in people with HBsAg-positive chronic hepatitis B.

Who is the study for?
This trial is for adults with chronic Hepatitis B who have a stable health condition, as shown by physical exams and heart tests. They must have had the infection for at least 6 months, not be treated or be on specific treatments with controlled virus levels. Their liver mustn't be too stiff (<=9 kPa), they can't have other hepatitis viruses or HIV, no signs of serious liver damage like cirrhosis, and women able to bear children and men with such partners must use effective birth control.Check my eligibility
What is being tested?
The study is testing how well new drug combinations including JNJ-73763989 and JNJ-56136379 work compared to existing treatments like Tenofovir in reducing the presence of Hepatitis B surface antigen in the liver. Participants will undergo treatment and then a liver biopsy to measure changes from the start of treatment.See study design
What are the potential side effects?
Potential side effects may include reactions at injection sites due to PegIFN-alpha-2a, kidney issues from Tenofovir disoproxil, gastrointestinal problems from Entecavir (ETV), headaches or nausea from Tenofovir alafenamide (TAF), and unknown risks from experimental drugs JNJ-73763989 and JNJ-56136379.

INSIGHT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~panel 1 and 2: post-dose on days 1, 29, 85, 169, 337
This trial's timeline: 3 weeks for screening, Varies for treatment, and panel 1 and 2: post-dose on days 1, 29, 85, 169, 337 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Panel 1 and 2: Absolute Change From Baseline in the Percentage of Hepatitis B Surface Antigen (HBsAg) Hepatocytes at Week 40
Secondary outcome measures
Panel 1 and 2: Change From Baseline in HBV-Specific Peripheral Blood T-cell Responses During the Study Intervention and Follow-up Phases
Panel 1 and 2: Change From Baseline in Intrahepatic Covalently Closed Circular DeoxyriboNucleic Acid (cccDNA) and Pre-genomic RiboNucleic Acid (pgRNA) Levels
Panel 1 and 2: Change From Baseline in Intrahepatic Immune Response
+10 more

INSIGHT Trial Design

2Treatment groups
Experimental Treatment
Group I: Panel 2: JNJ-73763989+ NAExperimental Treatment6 Interventions
Ongoing and new participants will receive JNJ-73763989 SC injection once every 4 weeks (last injection at Week 44) and NA treatment (ETV, tenofovir disoproxil or TAF tablets) once daily up to 48 weeks. Participants may receive optional treatment with PegIFN-alpha-2a after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Group II: Panel 1: JNJ-73763989+ NAExperimental Treatment6 Interventions
Ongoing and new participants will receive JNJ-73763989 subcutaneous (SC) injection once every 4 weeks (last injection at Week 44) and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil or tenofovir alafenamide [TAF] tablets) once daily up to 48 weeks. Participants may receive optional treatment with pegylated interferon alpha-2a (PegIFN-alpha-2a) after the Week 40 for a duration of either 12 or 24 weeks at the investigator's discretion. As per amendment-5, JNJ-56136379 is no longer included as part of the study intervention and all participants are counted as single arm in each panel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PegIFN-alpha-2a (Optional)
2021
Completed Phase 2
~30
Tenofovir disoproxil
2016
Completed Phase 3
~3910
JNJ-73763989
2021
Completed Phase 2
~820
JNJ-56136379
2017
Completed Phase 2
~1080
Entecavir (ETV)
2003
Completed Phase 3
~340
Tenofovir alafenamide (TAF)
2019
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,284 Total Patients Enrolled
8 Trials studying Hepatitis B
287 Patients Enrolled for Hepatitis B
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,881 Total Patients Enrolled
6 Trials studying Hepatitis B
216 Patients Enrolled for Hepatitis B

Media Library

JNJ-3989 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04585789 — Phase 2
Hepatitis B Research Study Groups: Panel 1: JNJ-73763989+ NA, Panel 2: JNJ-73763989+ NA
Hepatitis B Clinical Trial 2023: JNJ-3989 Highlights & Side Effects. Trial Name: NCT04585789 — Phase 2
JNJ-3989 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585789 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being taken on for this research endeavor?

"As stated on clinicaltrials.gov, this specific study is not presently accepting applicants; the trial was first posted in March 2021 and last updated November 2022. Despite that, there are still 509 other medical trials seeking participants at present."

Answered by AI

For what ailments is Tenofovir disoproxil typically prescribed?

"Tenofovir disoproxil is a popular treatment for virologically suppressed patients over the course of 3 months. This medication can also provide relief from tenofovir, treatment failure, and higher risk cases."

Answered by AI

How extensive is the patient pool for this clinical trial?

"Unfortunately, this trial is not accepting participants at the moment. The research was initially posted on March 11th 2021 and last modified on November 22nd 2022. For those who are seeking other studies, there are currently 381 active clinical trials recruiting patients with hepatitis b and 128 examining Tenofovir disoproxil as a treatment approach."

Answered by AI

Does this experimental research accommodate elderly participants?

"This medical trial is open to candidates of legal age, between 18 and 65 years old."

Answered by AI

Are there any precedent research studies associated with Tenofovir disoproxil?

"Currently, 128 research protocols concerning Tenofovir disoproxil are underway with 31 of them in the advanced Phase 3 stage. Although most trials for this compound take place at Boylston, Massachusetts, there are 1746 sites conducting studies on it across the globe."

Answered by AI

Is there a way for me to partake in this medical investigation?

"This trial is enrolling 24 individuals aged 18-65 with a documented diagnosis of Hepatitis b. Other prerequisites include an HBeAg positive status or virologically suppressed state, as well as having an acceptable BMI between 18 and 35kg/m^2"

Answered by AI

What hazards have been identified from using Tenofovir disoproxil?

"We rate Tenofovir disoproxil's safety as a 2 since this clinical trial is in Phase 2 - meaning that some evidence of its security has been collected, yet none for its efficacy."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Hôpital Beaujon
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
2021. "A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585789.
~6 spots leftby Apr 2025
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