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

• Status: Recruiting
• Trial end date: 2023-08-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Peginterferon alfa-2a

Criteria

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.