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NCT04225715CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 19 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
281 (actual)
First submitted
8 Jan 2020
Start date
5 Jul 2020
Primary completion date
19 Jul 2024
Lead sponsor
Hoffmann-La Roche
Diseases
Hepatitis B
NCT number
NCT04225715
EudraCT number
2019-002086-35

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 281
  • From 5 Jul 2020 to the primary completion date, 19 Jul 2024
  • 33 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

Other illness

  • 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.

Other

  • Pregnant or lactating women.
  • Electrocardiogram (ECG) with clinically significant abnormalities.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (33)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tokuda Hospital Sofia
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SofiaBulgariaUnknown status
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD
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SofiaBulgariaUnknown status
University Of Calgary
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CalgaryCanadaUnknown status
Uni of Alberta Hospital
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EdmontonCanadaUnknown status
Toronto Liver Centre
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TorontoCanadaUnknown status
Hospital San Juan de Dios La Serena
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La SerenaChileUnknown status
Beijing Friendship Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Nanfang Hospital, Southern Medical University
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GuangzhouChinaUnknown status
Ruijin Hospital Shanghai Jiaotong University School of Medicine
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
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BarcelonaSpainUnknown status
Hospital Alvaro Cunqueiro
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VigoSpainUnknown status
Hopital Beaujon
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ClichyFranceUnknown status
King College Hospital NHS Foundation Trust
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LondonUnited KingdomUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Chuncheon Sacred Heart Hospital
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Gangwon-DoSouth KoreaUnknown status
Asan Medical Center / Clinical Trial Center
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SeoulSouth KoreaUnknown status
Seoul National University College of Medicine - Liver Research Institute
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SeoulSouth KoreaUnknown status
SMG-SNU Boramae Medical Center
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SeoulSouth KoreaUnknown status
Middlemore Clinical Trials
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AucklandNew ZealandUnknown status
Auckland Clinical Studies Limited
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AucklandNew ZealandUnknown status
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
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Cluj-NapocaRomaniaUnknown status
HIVNAT
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Maharaj Nakorn Chiang Mai Hospital
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Chiang MaiThailandUnknown status
Changhua Christian Hospital
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Chang-huaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
National Cheng Kung Univ Hosp
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.