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
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tokuda Hospital Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Uni of Alberta Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Toronto Liver Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Hospital San Juan de Dios La Serena Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| Beijing Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital,Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Ruijin Hospital Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Alvaro Cunqueiro Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hopital Beaujon Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| King College Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Chuncheon Sacred Heart Hospital Coordinator of this site? Confirm its status | Gangwon-Do | South Korea | Unknown status |
| Asan Medical Center / Clinical Trial Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University College of Medicine - Liver Research Institute Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| SMG-SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Middlemore Clinical Trials Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Auckland Clinical Studies Limited Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Spitalul Clinic Judetean de Urgenta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| HIVNAT Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Chang-hua | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung Univ Hosp Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
Related publications
- Outcomes of nucleos(t)ide analogue discontinuation following finite xalnesiran-based therapies in chronic hepatitis B.JHEP Rep · 2026 · PMID 42456805
This page is information, not medical advice. Discuss any trial with your doctor.