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NCT04535544

PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-09-17

Completion Date

2025-03-05

Last Updated

2026-07-22

Healthy Volunteers

Conditions

Hepatitis D, Chronic

Interventions

DRUG

JNJ-73763989

JNJ-73763989 will be administered as a SC injection.

DRUG

Placebo

Matching placebo to JNJ-73763989 will be administered as a SC injection.

DRUG

Entecavir (ETV) monohydrate

ETV monohydrate film coated tablet will be administered orally.

DRUG

Tenofovir disoproxil

Tenofovir disoproxil film-coated tablet will be administered orally.

DRUG

Tenofovir alafenamide (TAF)

TAF film coated tablet will be administered orally.

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 * 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: * 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)

Locations (61)

Stanford University School of Medicine

Redwood City, California, United States

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

Irccs Ospedale Maggiore Di Milano

Milan, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

Rome, Italy

Ospedale Molinette, AO Città della Salute e della Scienza di

Torino, Italy

Tokyo Medical and Dental University Hospital

Bunkyō City, Japan

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

Hiroshima, Japan

National Hospital Organization Shikoku Cancer Center

Iizuka-shi, Japan

Ikeda City Hospital

Ikeda, Japan

Kumamoto University Hospital

Kumamoto, Japan

Kumamoto Shinto General Hospital

Kumamoto, Japan

Nagasaki University Hospital

Nagasaki, Japan

National Hospital Organization Nagasaki Medical Center

Nagasaki, Japan

University of the Ryukyus Hospital

Nakagami Gun, Japan

Nakagami Hospital

Okinawa, Japan

Suita Municipal Hospital

Suita, Japan

Osaka University Hospital

Suita-shi, Japan

Tokyo Metropolitan Bokutoh Hospital

Sumida Ku, Japan

New Zealand Clinical Research

Auckland, New Zealand

Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

Krasnoyarsk, Russia

St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

Saint Petersburg, Russia

Medical Company Hepatolog Ltd

Samara, Russia

Hosp Clinic de Barcelona

Barcelona, Spain

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. Marques de Valdecilla

Santander, Spain

Danderyds Sjukhus

Danderyd, Sweden

Skanes universitetssjukhus

Malmö, Sweden

Karolinska Universitetssjukhuset Huddinge

Stockholm, Sweden

Kaohsiung Medical University Chung Ho Memorial Hospital

Kaohsiung City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

China Medical University Hospital

Tiachung, Taiwan

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Ege University Medical of Faculty, Department of Gastroenterology

Izmir, Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, Turkey (Türkiye)

Karadeniz Teknik University Medical Faculty

Trabzon, Turkey (Türkiye)

Kings College Hospital

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)