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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis D, Chronic

In brief

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.

Key facts

Study ID

NCT04535544

Run by

Janssen Research & Development, LLC

People needed

52

Starts

2020-09-17

Expected to finish

2025-03-05

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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, 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)

Where it is running

• 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
• The First Bethune Hospital of Jilin University — Changchun, China
• West China Hospital Sichuan University — Chengdu, China
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China
• Guangzhou Eighth People's Hospital, Guangzhou Medical University — Guangzhou, China
• Nanfang Hospital — Guangzhou, China
• The First Affiliated Hospital Zhejiang University College of Medicine — Hangzhou, China
• Huashan Hospital Fudan University — Shanghai, China
• Hopital Beaujon — Clichy, France
• Hopital de La Croix Rousse — Lyon, France
• CHU de Nantes hotel Dieu — Nantes, France
• CHU Hopital Saint Antoine — Paris, France
• Chu Rennes Hopital Pontchaillou — Rennes, France
• Universitatsklinikum Essen — Essen, Germany
• Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1 — Frankfurt, Germany
• Medizinische Hochschule Hannover — Hanover, Germany
• Stanford University School of Medicine — Redwood City, California, United States

Full record on ClinicalTrials.gov

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