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Sponsor: Hoffmann-La Roche
Conditions: Hepatitis B, Chronic
Interventions: Nucleos(t)ide (NUC), CpAM (RO7049389), TLR7 (RO7020531), siRNA (RO7445482), PEG-IFN
Countries: Bulgaria, Canada, Chile, China, France, Hong Kong, New Zealand, Romania
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.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Sofia, Bulgaria
- Sofia, Bulgaria
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- Toronto, Ontario, Canada
- La Serena, Chile
- Beijing, China
- Changchun, China
- Chengdu, China
- Guangzhou, China
- Shanghai, China
- Shanghai, China
- Clichy, France
- Hong Kong, Hong Kong
- Auckland, New Zealand
- Auckland, New Zealand
- Cluj-Napoca, Romania
- Gangwon-Do, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Seoul, South Korea
- Vigo, Pontevedra, Spain
- Barcelona, Spain
- Chang-hua, Taiwan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taichung, Taiwan
- Tainan, Taiwan
- Taipei, Taiwan
- Bangkok, Thailand
- + 3 more on CT.gov