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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2026
  • participants needed
    190
  • sponsor
    Janssen Research & Development, LLC
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Updated on 2 January 2021
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Investigator
The Medical Research Network, LLC
Primary Contact
Johns Hopkins University School of Medicine (8.8 mi away) Contact
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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.

Description

JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection via ribonucleic acid interference mechanism. This phase 2 study is designed to evaluate safety and efficacy of JNJ-73763989 in HBV infected patients who are co-infected with HDV. The study consists of 2 parts: Part 1 will evaluate safety, tolerability and antiviral activity of JNJ-73763989 + NA while Part 2 will evaluate the safety and efficacy of the JNJ-73763989 + NA regimen in the treatment of HBV/HDV co-infection. Each part includes 3 phases: Screening phase (from 4 Week up to maximum of 8 weeks), Intervention phase (144 Week for Arm A and 148 Week for Arm B) and Follow-up phase (48 Week). The duration of individual study participation will be between 196 and 204 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HDV ribonucleic acid [RNA], HBV deoxyribonucleic acid [DNA] and antigens) , and pharmacokinetics will be assessed throughout the study.

Details
Treatment Placebo, Tenofovir disoproxil, Tenofovir alafenamide (TAF), JNJ-73763989, Entecavir (ETV) monohydrate
Clinical Study IdentifierNCT04535544
SponsorJanssen Research & Development, LLC
Last Modified on2 January 2021

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Hepatitis D, Chronic?
Do you have any of these conditions: Do you have Hepatitis D, Chronic??
Do you have any of these conditions: Do you have Hepatitis D, Chronic??
Do you have any of these conditions: Do you have Hepatitis D, Chronic??
Do you have any of these conditions: Do you have Hepatitis D, Chronic??
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)
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