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This study evaluated the safety, tolerability, and efficacy of combination therapies using new molecular entities in people with chronic hepatitis B (CHB) who have preserved liver function and no significant fibrosis or cirrhosis. Its platform design allows several combinations to be compared against a common control group and new treatment arms to be added over time; the agents studied included a nucleos(t)ide (NUC), RO7049389 (Linvencorvir, RG7907), RO7020531 (Ruzotolimod, RG7854), the siRNA RO7445482 (Xalnesiran, RG6346), PEG-IFN (Pegasys®), and RO7191863 (Cadapersen, RG6084). The Phase 2 study enrolled participants with a body mass index between 18 and 32 kg/m2 who had been on established NUC monotherapy (entecavir or tenofovir) for at least 12 months.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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.