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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
Must not have
Signs of hepatocellular carcinoma (HCC)
Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 196

Summary

This trial is testing a new drug called JNJ-73763989 combined with an existing medication to treat hepatitis D virus (HDV). The goal is to see if this combination works better than the current treatment alone. The new drug is expected to enhance the effectiveness of the existing medication.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent health checks show no major concerns.
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I am using or my partner is using highly effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with liver cancer.
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I cannot take entecavir, tenofovir disoproxil, or TAF due to health reasons.
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I have signs of severe liver problems as outlined in the study.
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My liver disease is not caused by hepatitis B or D.
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I have or had a serious skin condition or reaction to medication.
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I have had or am planning to have major surgery, or I have received an organ transplant.
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I plan to try for a child during the study.
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I am not pregnant, breastfeeding, nor planning to become pregnant soon.
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I have a history of heart rhythm problems or significant heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 196
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 196 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in Combination With Normal Alanine Aminotransferase (ALT) at Week 48 (Multiple Imputation Approach)
Double-blind: Part 2: Percentage of Participants With HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination With ALT at Week 48 (Multiple Imputation Approach)
Secondary study objectives
Change from Baseline Over Time in HBV DNA
Change from Baseline Over Time in HBeAg
Change from Baseline Over Time in HBsAg
+34 more

Side effects data

From 2022 Phase 2 trial • 130 Patients • NCT04129554
22%
Headache
21%
Glomerular Filtration Rate Decreased
20%
Covid-19
14%
Asthenia
13%
Hypertension
13%
Fatigue
12%
Nasopharyngitis
12%
Back Pain
11%
Arthralgia
11%
Pain in Extremity
9%
Pyrexia
8%
Nausea
7%
Vomiting
7%
Myalgia
7%
Alanine Aminotransferase Increased
6%
Cough
5%
Injection Site Pain
5%
Anaemia
5%
Abdominal Pain Upper
5%
Dyspepsia
5%
Upper Respiratory Tract Infection
5%
Musculoskeletal Chest Pain
4%
Seasonal Allergy
4%
Aspartate Aminotransferase Increased
4%
Vaccination Site Pain
4%
Influenza Like Illness
4%
Urinary Tract Infection
4%
Constipation
4%
Vertigo
4%
Blood Bilirubin Increased
4%
Diarrhoea
4%
Pruritus
4%
Renal Impairment
4%
Dyspnoea
4%
Abdominal Discomfort
4%
Rhinitis
4%
Neck Pain
2%
Alopecia
2%
Pollakiuria
2%
Haematoma
2%
Chills
2%
Bronchitis
2%
Ocular Hyperaemia
2%
Respiratory Tract Infection
2%
Sinusitis
2%
Illness
2%
Pain
2%
Blood Pressure Diastolic Increased
2%
Oropharyngeal Pain
2%
Abdominal Pain
2%
Dizziness
2%
Hepatitis B Dna Increased
2%
Lipase Increased
2%
Dental Caries
2%
Haemorrhoids
2%
Dyslipidaemia
2%
Pharyngitis
2%
Rash
2%
Feeling Abnormal
2%
Creatinine Renal Clearance Decreased
2%
Gastrooesophageal Reflux Disease
1%
Cytomegalovirus Infection Reactivation
1%
Decreased Appetite
1%
Rectal Haemorrhage
1%
Testicular Pain
1%
Contusion
1%
Hypoaesthesia
1%
Hepatic Cancer
1%
Paraesthesia
1%
Chest Pain
1%
Peripheral Swelling
1%
Vaginal Haemorrhage
1%
Anxiety
1%
Thermal Burn
1%
Palpitations
1%
Amylase Increased
1%
Sciatica
1%
Cholangiocarcinoma
1%
Tendonitis
1%
Inguinal Hernia
1%
Muscle Spasms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 1: JNJ-73763989 (200 Milligrams [mg])+JNJ-56136379 (250 mg)+NA
Arm 2: Nucleos(t)Ide Analog (NA)

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 for at least 96 weeks in Part 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 for at least 48 weeks in Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
2021
Completed Phase 3
~3930
Entecavir (ETV) monohydrate
2021
Completed Phase 2
~180
Tenofovir alafenamide (TAF)
2019
Completed Phase 2
~330
JNJ-73763989
2021
Completed Phase 2
~880

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The investigational drug JNJ-73763989 likely targets HDV replication, reducing the viral load and preventing liver damage. Nucleos(t)ide analogs inhibit viral replication by mimicking the building blocks of viral DNA/RNA, preventing the virus from multiplying. This combination is significant for Chronic Hepatitis D patients as it addresses both the replication of the hepatitis D virus and the underlying hepatitis B virus, offering a comprehensive approach to managing the co-infection.
New approaches in the management of chronic hepatitis B: role of tenofovir.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
1,007 Previous Clinical Trials
6,400,995 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
772 Previous Clinical Trials
3,979,096 Total Patients Enrolled

Media Library

Entecavir (ETV) monohydrate (Nucleos(t)ide Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04535544 — Phase 2
Chronic Hepatitis D Research Study Groups: Immediate Active Treatment arm: JNJ-73763989 + NA, Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA
Chronic Hepatitis D Clinical Trial 2023: Entecavir (ETV) monohydrate Highlights & Side Effects. Trial Name: NCT04535544 — Phase 2
Entecavir (ETV) monohydrate (Nucleos(t)ide Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535544 — Phase 2
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