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Nucleos(t)ide Analog
JNJ-73763989 + Antivirals for Hepatitis B and D Co-Infection (REEF-D 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
Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 204
Awards & highlights
REEF-D Trial Summary
This trial will compare the effectiveness of a new hepatitis drug regimen against the current standard of care.
Who is the study for?
This trial is for adults with chronic hepatitis B and D co-infection, stable health, no liver disease from other causes, no recent cancer, and not pregnant. They must have certain levels of HDV RNA in their blood and can't be too sick with liver problems or have a history of heart issues.Check my eligibility
What is being tested?
The study tests the effectiveness of JNJ-73763989 combined with nucleos(t)ide analogs (like Tenofovir or Entecavir) against hepatitis D virus compared to just the nucleos(t)ide analogs alone in treating co-infected patients.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site for JNJ-73763989, kidney issues from Tenofovir use, digestive disturbances from Entecavir, as well as general symptoms like fatigue or headaches.
REEF-D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My recent health checks show no major concerns.
Select...
I am using or my partner is using highly effective birth control.
REEF-D Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 204
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 204
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 HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT at Week 48
Secondary outcome measures
Area Under the Plasma Concentration-time Curve (AUC) of JNJ-73763989
Change from Baseline Over Time in HBV DNA
Change from Baseline Over Time in HBeAg
+35 moreSide effects data
From 2024 Phase 2 trial • 24 Patients • NCT0458578940%
Headache
30%
Covid-19
20%
Nasopharyngitis
20%
Thrombocytopenia
20%
Nausea
20%
Decreased Appetite
20%
Fatigue
20%
Pyrexia
20%
Myalgia
10%
Asthenia
10%
Alanine Aminotransferase Increased
10%
Injection Site Erythema
10%
Blood Creatine Phosphokinase Increased
10%
Procedural Pain
10%
Neutropenia
10%
Eye Pruritus
10%
Root Canal Infection
10%
Pruritus
10%
Urinary Tract Infection
10%
Oropharyngeal Pain
10%
Influenza Like Illness
10%
Glomerular Filtration Rate Decreased
10%
Tinnitus
10%
Diarrhoea
10%
Injection Site Bruising
10%
Bronchitis
10%
Body Temperature Increased
10%
Arthralgia
10%
Musculoskeletal Pain
10%
Sciatica
10%
Depressed Mood
100%
80%
60%
40%
20%
0%
Study treatment Arm
Panel 2
Panel 1
REEF-D Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Immediate Active Treatment arm: JNJ-73763989 + NAExperimental Treatment4 Interventions
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 2.
Group II: Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NAPlacebo Group5 Interventions
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 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
2016
Completed Phase 3
~3910
Entecavir (ETV) monohydrate
2021
Completed Phase 2
~180
Tenofovir alafenamide (TAF)
2019
Completed Phase 2
~330
JNJ-73763989
2021
Completed Phase 2
~820
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,256 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,853 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with liver cancer.I cannot take entecavir, tenofovir disoproxil, or TAF due to health reasons.I have had cancer within the last 5 years.I have signs of severe liver problems as outlined in the study.I do not have severe liver disease or my liver disease is mild (Child Pugh A), and my platelet count is high enough for Part-2.My liver disease is not caused by hepatitis B or D.I have or had a serious skin condition or reaction to medication.I have had or am planning to have major surgery, or I have received an organ transplant.I plan to try for a child during the study.My recent health checks show no major concerns.I am not pregnant, breastfeeding, nor planning to become pregnant soon.I have a history of heart rhythm problems or significant heart disease.I have had both hepatitis B and D for at least 6 months.I am using or my partner is using highly effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Active Treatment arm: JNJ-73763989 + NA
- Group 2: Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA
Awards:
This trial has 0 awards, including: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.
Am I eligible to join this scientific experiment?
"The selection criteria for this clinical trial necessitates that participants are diagnosed with chronic hepatitis D and between 18 to 65 years of age. The aim is to onboard 190 people into the study."
Answered by AI
Is this clinical experiment seeking out participants who are elderly?
"This medical study is only open to adults aged 18-65, with 44 trials available for minors and 327 trials offered to those over 65."
Answered by AI
Could you elucidate the safety profile of JNJ-73763989?
"There is limited prior clinical evidence indicating the safety of JNJ-73763989, so it received a rating of 2. This drug has been tested in Phase 2 trials but efficacy data is still lacking."
Answered by AI
What medical condition is JNJ-73763989 generally administered to treat?
"JNJ-73763989 is frequently prescribed to virologically suppressed patients after a duration of 3 months. This pharmaceutical intervention has also been proven effective in addressing tenofovir, treatment failure issues, and cases involving high risk individuals."
Answered by AI
Are there any reports of previous research studies utilizing JNJ-73763989?
"Currently, 128 clinical trials for JNJ-73763989 are underway and 31 of them have advanced to Phase 3. Most studies occur in Boylston, Massachusetts but a total of 1746 medical sites are participating."
Answered by AI
What is the current limit on participants for this trial?
"In order to continue, this clinical trial requires 190 qualified members. Individuals can join from Harvard Medical School - Massachusetts General Hospital in Boston and Stanford University School of Medicine located in Redwood City, California."
Answered by AI
Are recruitment efforts still ongoing for this research project?
"Affirmative. Clinicaltrials.gov has information that suggests this research is currently processing applications. This study was first released on September 17th 2020, and the last edit to its description occurred on November 22nd 2022; 190 participants are sought from 3 different treatment sites."
Answered by AI
Who else is applying?
What site did they apply to?
I.D. Care, Inc.
What portion of applicants met pre-screening criteria?
Did not meet criteria
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