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Combination Therapy for Hepatitis B (OCTOPUS-1 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
Participants must have fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) or a liver biopsy result classified as metavir F0-F2
Participants must have chronic hepatitis B virus (HBV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 72
Awards & highlights

OCTOPUS-1 Trial Summary

This trial is testing if the study intervention can lower HBsAg levels in people with hepatitis B.

Who is the study for?
This trial is for adults with chronic hepatitis B who have a liver stiffness of <=9.0 kPa or mild to moderate liver scarring (metavir F0-F2). People with other types of hepatitis, HIV, signs of advanced liver disease like cirrhosis or cancer, and those at risk for immune-mediated diseases cannot participate.Check my eligibility
What is being tested?
The study tests the effectiveness of JNJ-73763989 combined with nucleos(t)ide analogs (like Tenofovir Disoproxil or Entecavir) and a PD-1 inhibitor in reducing hepatitis B surface antigen levels after 24 weeks.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to the PD-1 inhibitor, as well as common drug-related issues such as fatigue, digestive discomfort, and possible changes in blood test results.

OCTOPUS-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver is relatively healthy, with low stiffness or mild to moderate fibrosis.
Select...
I have chronic hepatitis B.

OCTOPUS-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 72 for reporting.

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 who Achieve Hepatitis B Surface Antigen (HBsAg) Seroclearance
Secondary outcome measures
Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels
Change from Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels
Number of Participants with Abnormalities in Vital Signs, Physical Examinations, Clinical Laboratory Tests, 12-lead Electrocardiograms (ECGs)
+11 more

Side effects data

From 2024 Phase 2 trial • 24 Patients • NCT04585789
30%
Headache
20%
Fatigue
20%
Vomiting
20%
Eczema
20%
Oropharyngeal Pain
20%
Abdominal Pain Lower
20%
Dizziness
10%
Alanine Aminotransferase Increased
10%
Injection Site Erythema
10%
Asthenia
10%
Mood Swings
10%
Rhinorrhoea
10%
Renal Tubular Disorder
10%
Pruritus
10%
Nasal Congestion
10%
Diarrhoea
10%
Anaemia
10%
Alopecia
10%
Gastritis
10%
Abdominal Pain Upper
10%
Amylase Increased
10%
Chills
10%
Myalgia
10%
Musculoskeletal Chest Pain
10%
Neck Pain
10%
Groin Pain
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

OCTOPUS-1 Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: JNJ-73763989 + PD-1 Inhibitor + NAExperimental Treatment5 Interventions
Participants will receive JNJ-73763989 SC injections and multiple doses of PD-1 inhibitor as IV infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, TAF or ETV).
Group II: Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)Experimental Treatment5 Interventions
Participants will receive JNJ-73763989 subcutaneous (SC) injections and single dose of programmed cell death protein receptor-1 (PD-1) inhibitor as intravenous (IV) infusion. Participants will also receive background treatment with NA (either tenofovir disoproxil, tenofovir alafenamide [TAF] or entecavir [ETV]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-73763989
2021
Completed Phase 2
~820
Tenofovir Disoproxil
2018
Completed Phase 4
~190
Tenofovir Alafenamide
2017
Completed Phase 4
~1580
Entecavir
2003
Completed Phase 4
~3670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,271 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,868 Total Patients Enrolled

Media Library

Entecavir (NA) Clinical Trial Eligibility Overview. Trial Name: NCT05275023 — Phase 2
Chronic Hepatitis B Research Study Groups: Arm 2: JNJ-73763989 + PD-1 Inhibitor + NA, Arm 1: JNJ-73763989 + PD-1 Inhibitor + Nucleos(t)ide analog (NA)
Chronic Hepatitis B Clinical Trial 2023: Entecavir Highlights & Side Effects. Trial Name: NCT05275023 — Phase 2
Entecavir (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05275023 — Phase 2

Frequently Asked Questions

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

Does the research protocol stipulate an upper limit on participants' age?

"This trial is open for those aged 18 to 55. However, there are 26 trials specially catered towards individuals under the age of majority, and 231 studies available for people over 65 years old."

Answered by AI

Has JNJ-73763989 received recognition from the Food and Drug Administration?

"Because this is an early-phase clinical trial, we have assigned JNJ-73763989 a safety rating of 2. This score accounts for some existing data related to the drug's harmlessness while taking into consideration that efficacy has yet to be established."

Answered by AI

Are there any available opportunities to join this clinical trial as a participant?

"The clinical trial is actively seeking participants, according to the details posted on clinicaltrials.gov. This study was first shared publically on June 30th 2022 and its information has been updated as recently as November 22nd 2022."

Answered by AI

What are the inclusion criteria for participation in this experiment?

"This clinical trial is enrolling 44 individuals between 18 and 55 years old who have chronic hepatitis b. To be eligible, patients must also have a liver stiffness measurement of no more than 9 kPa or an F0-F2 Metavir score according to biopsy results."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Chu Rennes - Hopital Pontchaillou
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants
2022. "An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death Protein Receptor-1 (PD-1) Inhibitor in Chronic Hepatitis B Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05275023.
~13 spots leftby Apr 2025
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