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

• Status: Recruiting
• Trial end date: 2026-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Entecavir; Tenofovir

Criteria

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

• Hepatitis D RNA (HDV RNA) greater than (>) 1000 international units per milliliter (IU/mL) at screening

• 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

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

• Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content

• Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information

• Participants who have taken any therapies disallowed per protocol

• Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention

• Male participants who plan to father a child while enrolled

• Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant

• Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)