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A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

NCT04535544•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
•Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
•For Part 1: hepatitis D RNA (HDV RNA) greater than or equal to (\>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values \>= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (\<=) 10000 IU/mL at screening or HDV RNA values at screening are \<= 100000 IU/mL
•Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
•Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included
•Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
•Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of \>= 140000 per deciliter (dL) for enrollment into Part-2

Exclusion Criteria

•Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
•History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
•Evidence of liver disease of non-HBV/HDV etiology
•Signs of hepatocellular carcinoma (HCC)
•Significant laboratory abnormalities as defined in the protocol at screening
•Participants with a history of malignancy within 5 years before screening
•Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
•History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
•Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
•History of or current clinically significant skin disease or drug rash
+7 more criteria

Locations (61)

Stanford University School of Medicine

Redwood City, California, United States

Harvard Medical School Massachusetts General Hospital

Boston, Massachusetts, United States

Royal Prince Alfred Hospital

Camperdown, Australia

Western Health

Footscray, Australia

Westmead Hospital

Westmead, Australia

Centro Oncológico De Roraima

Boa Vista, Brazil

Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado

Manaus, Brazil

Cepem - Centro de Pesquisa Em Medicina Tropical

Porto Velho, Brazil

Beijing Ditan Hospital Capical Medical University

Beijing, China

Peking University People s Hospital

Beijing, China

Key Dates

Start Date

September 17, 2020

Primary Completion Date

October 19, 2023

Completion Date

March 5, 2025

Last Updated

April 25, 2025

Enrollment

ACTUAL participants

Conditions

Hepatitis D, Chronic

Interventions

JNJ-73763989

DRUG

Placebo

DRUG

Entecavir (ETV) monohydrate

DRUG

Tenofovir disoproxil

DRUG

Tenofovir alafenamide (TAF)

DRUG

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

NCT04166266

Hepatitis D, ChronicHepatitis B, Chronic

View study

ACTIVE_NOT_RECRUITINGNA

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

NCT06603311

Compensated Liver Disease (Disorder)Hepatitis D, Chronic

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

Inclusion Criteria

Exclusion Criteria

National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses

Finite Treatment of Hepatitis Delta With Bulevirtide: Identification of Biomarkers Associated With Sustained Control of HDV Infection

SOLSTICE: Combination Therapy for the Treatment of Chronic Hepatitis D Infection.

Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection

A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)