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HBV Capsid Assembly Modulator

JNJ-73763989 for Chronic Hepatitis B (REEF-1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Janssen Sciences Ireland UC
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 days 1, 29, 85, 169 and 337
Awards & highlights

REEF-1 Trial Summary

This study is evaluating whether a drug can be used to treat a virus.

Eligible Conditions
  • Chronic Hepatitis B

REEF-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 29, 85, 169 and 337
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 29, 85, 169 and 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
Percentage of Participants Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48
Secondary outcome measures
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA
+21 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

REEF-1 Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 5: Placebo + JNJ-56136379 + NAExperimental Treatment3 Interventions
Participants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Group II: Arm 4: JNJ-73763989 (low dose) + Placebo + NAExperimental Treatment3 Interventions
Participants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Group III: Arm 3: JNJ-73763989 (medium dose) + Placebo + NAExperimental Treatment3 Interventions
Participants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Group IV: Arm 2: JNJ-73763989 (high dose) + Placebo + NAExperimental Treatment3 Interventions
Participants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Group V: Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NAExperimental Treatment3 Interventions
Participants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) up to 48 weeks.
Group VI: Arm 6 (Control): Placebo + Placebo + NAPlacebo Group3 Interventions
Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-73763989
2021
Completed Phase 2
~820
Placebo for JNJ-73763989
2019
Completed Phase 2
~610
JNJ-56136379
2017
Completed Phase 2
~1080
Placebo for JNJ-56136379
2019
Completed Phase 2
~610
Nucleos(t)ide Analog (NA)
2019
Completed Phase 2
~480

Find a Location

Who is running the clinical trial?

Janssen Sciences Ireland UCLead Sponsor
27 Previous Clinical Trials
2,237 Total Patients Enrolled
Janssen Sciences Ireland UC Clinical TrialStudy DirectorJanssen Sciences Ireland UC
22 Previous Clinical Trials
2,077 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
2019. "A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03982186.
~83 spots leftby Apr 2025
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