A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Last updated: N/A
Sponsor: Janssen Sciences Ireland UC
Overall Status: Active - Recruiting

Phase

2

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT04288310
CR108679
2019-002674-31
73763989PAHPB2002
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Medically stable based on physical examination, medical history, vital signs,electrocardiogram (ECG) at screening

  • Chronic hepatitis B virus (HBV) infection with documentation at least 6 months priorto screening

  • Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatmentfor at least 24 months prior to screening

  • Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units perMilliliter (IU/mL) at screening

  • Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m^2), extremesincluded

  • Highly effective contraceptive measures in place for female participants ofchildbearing potential or male participants with female partners of childbearingpotential

  • Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) atscreening

Exclusion

Exclusion Criteria:

  • Evidence of infection with hepatitis A, C, D or E virus infection or evidence of humanimmunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening

  • History or evidence of clinical signs/symptoms of hepatic decompensation including butnot limited to: portal hypertension, ascites, hepatic encephalopathy, esophagealvarices or any laboratory abnormalities indicating a reduced liver function as definedin the protocol

  • Evidence of liver disease of non-HBV etiology

  • History or signs of cirrhosis or portal hypertension (nodules, no smooth livercontour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellularcarcinoma (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 ofsignificant or unstable cardiac disease

  • Participants with any current or previous illness for which, in the opinion of theinvestigator and/or sponsor, participation would not be in the best interest of theparticipant

  • History of or current clinically significant skin disease or drug rash

  • Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 ortheir excipients or to 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

Study Design

Total Participants: 120
Study Start date:
November 06, 2019
Estimated Completion Date:
February 18, 2022

Study Description

Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is effective at suppressing viral DNA formation and lowering virus concentration in blood to levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism but rarely lead to functional cure defined as sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for treatment of chronic HBV infection. The aim of study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after completion of all study interventions at Week 48) without restarting NA treatment in HBeAg negative virologically suppressed chronic hepatitis B (CHB) infected participants who received NA treatment for at least 2 years prior to screening. The study will be 2.3 years and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital signs, and physical examinations.

Connect with a study center

  • SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)

    Antwerpen, 2060
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc

    Bruxelles, 1200
    Belgium

    Active - Recruiting

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hôpital Beaujon

    Clichy, 92110
    France

    Active - Recruiting

  • Hopital de La Croix Rousse

    Lyon, 69004
    France

    Active - Recruiting

  • Hopital Saint Joseph

    Marseille, 13008
    France

    Active - Recruiting

  • Hopital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • Chu Rennes - Hopital Pontchaillou

    Rennes, 35033
    France

    Active - Recruiting

  • CHU Nancy Brabois

    Vandoeuvre les Nancy, 54511
    France

    Active - Recruiting

  • Hopital Paul Brousse

    Villejuif, 94800
    France

    Active - Recruiting

  • EPIMED GmbH

    Berlin, 12157
    Germany

    Site Not Available

  • Universitatsklinikum Essen

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

    Frankfurt, 60590
    Germany

    Site Not Available

  • Universitatsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • ICH Study Center GmbH & Co. KG

    Hamburg, 20146
    Germany

    Active - Recruiting

  • University Medical Center

    Hamburg, D-20246
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitatsklinikum Leipzig

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, 55121
    Germany

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico G. Martino

    Messina, 98124
    Italy

    Active - Recruiting

  • Irccs Ospedale Maggiore Di Milano

    Milano, 20122
    Italy

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara

    Modena, 41126
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

    Active - Recruiting

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

    Rome, 00161
    Italy

    Active - Recruiting

  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy

    Bydgoszcz, 85-030
    Poland

    Active - Recruiting

  • Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska

    Gdansk, 80-462
    Poland

    Active - Recruiting

  • ID Clinic

    Myslowice, 41-400
    Poland

    Active - Recruiting

  • SP ZOZ Wroclawskie Centrum Zdrowia

    Wroclaw, 50-136
    Poland

    Active - Recruiting

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08028
    Spain

    Active - Recruiting

  • Hosp. Univ. Vall D'Hebron

    Barcelona, 8035
    Spain

    Active - Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Madrid, 28222
    Spain

    Active - Recruiting

  • Hosp. Univ. Marques de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hosp. Gral. Univ. Valencia

    Valencia, 46014
    Spain

    Active - Recruiting

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH
    United Kingdom

    Active - Recruiting

  • North Manchester General Hospital

    Crumpsall, M8 5RB
    United Kingdom

    Active - Recruiting

  • Glasgow Royal Infirmary

    Glasgow, G31 2ER
    United Kingdom

    Active - Recruiting

  • Grahame Hayton Unit

    London, E1 1BB
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 9RF
    United Kingdom

    Active - Recruiting

  • St George's, University of London and St George's University Hospitals NHS Foundation Trust

    London, SW17 0RE
    United Kingdom

    Active - Recruiting

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