A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

  • Infectious Diseases
  • Chronic Hepatitis B
  • Hepatitis B Virus
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Cities
  • Auckland
  • Barcelona
  • bei-jing-shi
  • Beijing
  • Busan
  • Calgary
  • Chang Wat Chiang Mai
  • chang-chun-shi
  • Changhua County
  • Cheng Du Shi
  • Chuncheon
  • Clichy
  • Cluj-Napoca
  • Edmonton
  • guang-zhou-shi
  • Hong Kong Island
  • Kaohsiung City
  • Krung Thep Maha Nakhon
  • La Serena
  • Liverpool
  • London
  • Lyon
  • Majadahonda
  • New Territories
  • Ottawa
  • Pontevedra
  • Rialto
  • San Francisco
  • Seoul
  • shang-hai-shi
  • Sofia
  • Stara Zagora
  • Taichung City
  • Tainan City
  • Taipei City
  • Toronto
  • Vandœuvre-lès-Nancy
  • Vigo
Trial Identifier:

NCT04225715 2019-002086-35 WV41073

  • Asan Medical Center / Clinical Trial Center

    05505SeoulSouth Korea
  • Auckland Clinical Studies Limited

    12 Queen St1010AucklandNew Zealand
  • Beijing Friendship Hospital

    36 永安路100052bei-jing-shiChina
  • Capital Medical University (CMU) - Beijing Ditan Hospital; Liver Center (Center for Liver Diseases)

    BeijingChina
  • Changhua Christian Hospital

    176 Zhonghua Rd500Changhua CountyTaiwan
  • China Medical University Hospital; Internal Medicine

    Taichung CityTaiwan
  • Chuncheon Sacred Heart Hospital

    24253ChuncheonSouth Korea
  • Hivnat; Thai Red Cross Center

    104 Thanon Ratchadamri10330Krung Thep Maha NakhonThailand
  • Hopital Beaujon; Chir 2

    ClichyFrance
  • Hopital Brabois Adultes; Service Médecine Interne Hématologie

    4 Av. de Bourgogne54500Vandœuvre-lès-NancyFrance
  • Hopital de la Croix-Rousse ? Groupement Hospitalier Nord; Pharmacie / Secteur Essais Cliniques

    103 Gd Rue de la Croix-Rousse69004LyonFrance
  • Hospital Alvaro Cunqueiro; Servicio de Farmacia. Planta -1

    341 Estrada de Clara Campoamor36312VigoSpain
  • Hospital Montecelo

    PontevedraSpain
  • Hospital San Juan de Dios La Serena

    916 Av. Balmaceda1710218La SerenaChile
  • Hospital Universitario Puerta de Hierro

    1 C. Joaquín Rodrigo28222MajadahondaSpain
  • Huashan Hospital, Fudan University

    796 江苏路200031shang-hai-shiChina
  • Inje University Busan Paik Hospital; Clinical Trial Center

    47388BusanSouth Korea
  • Inland Empire Liver Foundation

    2006 N Riverside Ave92377RialtoUnited States
  • Kaohsiung Medical University Chung-Ho Memorial Hospital; Pharmacy

    100號 Ziyou 1st Rd80756Kaohsiung CityTaiwan
  • King Chulalongkorn Memorial Hospital

    1873 Thanon Rama IV10330Krung Thep Maha NakhonThailand
  • King College Hospital NHS Foundation Trust

    SE5 9RSLondonUnited Kingdom
  • Maharaj Nakorn Chiang Mai Hospital

    110 Intrawarorot Road Soi 250200Chang Wat Chiang MaiThailand
  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    6000Stara ZagoraBulgaria
  • Middlemore Clinical Trials

    2025AucklandNew Zealand
  • Nanfang Hospital, Southern Medical University

    1838 Guang Zhou Da Dao Bei510515guang-zhou-shiChina
  • National Cheng Kung Univ Hosp

    Tainan CityTaiwan
  • National Taiwan University Hospital

    7號 Zhongshan S Rd100Taipei CityTaiwan
  • Ottawa Hospital

    501 Smyth RdK1H 8L6OttawaCanada
  • Peking University People's Hospital

    11 西直门南大街100033bei-jing-shiChina
  • Prince of Wales Hospital

    New TerritoriesHong Kong
  • Pusan National University Hospital

    BusanSouth Korea
  • Queen Mary Hospital

    Hong Kong IslandHong Kong
  • Quest Clinical Research

    2300 Sutter St94115San FranciscoUnited States
  • Royal Liverpool University Hospital

    L7 8YELiverpoolUnited Kingdom
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    381 He Fei Lu200025shang-hai-shiChina
  • Seoul National University College of Medicine, Liver Research Institute

    110-460SeoulSouth Korea
  • Siriraj Hospital

    2 Thanon Wang Lang10700Krung Thep Maha NakhonThailand
  • SMG-SNU Boramae Medical Center

    SeoulSouth Korea
  • Spitalul Clinic Judetean de Urgenta Cluj Napoca

    Cluj-NapocaRomania
  • St George's Hospital

    SW17 0QTLondonUnited Kingdom
  • Taichung Veterans General Hospital

    1650號 台灣大道四段40705Taichung CityTaiwan
  • The First Hospital of Jilin University

    130021chang-chun-shiChina
  • Tokuda Hospital Sofia; Hematology department

    51Б bul. "Nikola Y. Vaptsarov"1407SofiaBulgaria
  • Toronto General Hospital

    585 University AveM5G 2N2TorontoCanada
  • Toronto Liver Centre

    1664 Dufferin StM6H 3M1TorontoCanada
  • Uni of Alberta Hospital

    T6G 2S2EdmontonCanada
  • University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD; clinical hematology

    15 bulevard "akad. Ivan Evst. Geshov"1000SofiaBulgaria
  • University of Calgary; HSC- Faculty of Medicine

    3280 Hospital Dr NWT2N 4Z6CalgaryCanada
  • Vall d?Hebron Institute of Oncology (VHIO), Barcelona

    08035BarcelonaSpain
  • West China Hospital, Sichuan University

    37 Guo Xue Xiang610041Cheng Du ShiChina
  • Yonsei Uni College of Medicine, Severance Hospital; Internal Medicine Dept.

    03722SeoulSouth Korea
    Show study locations

    The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

    The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

    Results Disclaimer

    Study Summary

    This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.

    Hoffmann-La Roche Sponsor
    Phase 2 Phase
    NCT04225715, WV41073, 2019-002086-35 Trial Identifier
    Nucleos(t)ide (NUC), CpAM (RO7049389), TLR7 (RO7020531), siRNA (RO7445482), PEG-IFN, PD-L1 LNA (RO7191863) Treatments
    Hepatitis B, Chronic Condition
    Official Title

    A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

    Eligibility Criteria

    All Gender
    ≥18 Years & ≤ 65 Years Age
    No Healthy Volunteers
    Inclusion Criteria
    • Body mass index between 18 and 32 kg/m2 inclusive.
    • Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening.
    • HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening.
    • Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening.
    • Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
    • Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.
    Exclusion Criteria
    • Pregnant or lactating women.
    • Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
    • History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
    • History of or suspicion of Hepatocellular Carcinoma (HCC).
    • Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
    • Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
    • Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
    • History of alcohol abuse and/or drug abuse within one year of randomization.
    • History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
    • Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
    • Electrocardiogram (ECG) with clinically significant abnormalities.
    • Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

    About Clinical Research

    What is a clinical trial? Why should I consider taking part in a clinical trial? And why does Genentech conduct clinical trials?

    Find out now