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

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Brief Title

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

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

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT at Week 48

Secondary Outcome

 Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND at Week 48

Condition

Hepatitis D, Chronic

Intervention

JNJ-73763989

Study Arms / Comparison Groups

 Immediate Active Treatment arm: JNJ-73763989 + NA
Description:  Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir [ETV], tenofovir disoproxil, or tenofovir alafenamide [TAF]) once daily for 144 Weeks in Part 1 and 2.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

190

Start Date

September 17, 2020

Completion Date

July 30, 2026

Primary Completion Date

June 7, 2023

Eligibility 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)
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Janssen Research & Development, LLC Clinical Trial, 844-434-4210, [email protected]

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT04535544

Organization ID

CR108868

Secondary IDs

2020-001249-37

Responsible Party

Sponsor

Study Sponsor

Janssen Research & Development, LLC


Study Sponsor

Janssen Research & Development, LLC Clinical Trial, Study Director, Janssen Research & Development, LLC


Verification Date

August 2021