NCT04225715

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 281 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Nucleos(t)ide (NUC)	Nucleos(t)ide (NUC) will be administered orally
DRUG	CpAM (RO7049389)	CpAM (RO7049389) will be administered orally
DRUG	TLR7 (RO7020531)	TLR7 (RO7020531) will be administered orally
DRUG	siRNA (RO7445482)	siRNA (RO7445482) will be administered subcutaneously
DRUG	PEG-IFN	PEG-IFN will be administered subcutaneously
DRUG	PD-L1 LNA (RO7191863)	PD-L1 LNA (RO7191863) will be administered subcutaneously

Timeline

• Start date: 2020-07-05
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2020-01-13
• Last updated: 2025-09-19
• Results posted: 2025-09-19

Locations

33 sites across 13 countries: Bulgaria, Canada, Chile, China, France, Hong Kong, New Zealand, Romania, South Korea, Spain, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study