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

Trial ID or NCT#

NCT04535544

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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)
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Investigator(s)

Paul Kwo
Paul Kwo
Hepatologist, Transplant hepatologist, Gastroenterologist
Professor of Medicine (Gastroenterology and Hepatology)

View on ClinicalTrials.gov