CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 281 enrolled
Drug / intervention
Nucleos(t)ide (NUC) +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04225715
NCT04225715Phase 2Completed
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A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

Hoffmann-La Roche·interventional·Posted Jan 13, 2020·Updated Sep 19, 2025

In Brief

A Phase 2 clinical trial evaluating Nucleos(t)ide (NUC), CpAM (RO7049389), and 4 other interventions for Hepatitis B, Chronic. Completed, enrolled 281 participants across 33 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic
CountriesBulgaria, Canada, Chile, China, France, Hong Kong, New Zealand, Romania, South Korea, Spain, Taiwan, Thailand, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartJul 5, 2020
Primary CompletionJul 19, 2024
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 6.5 years ago

Interventions

Nucleos(t)ide (NUC)drug

Nucleos(t)ide (NUC) will be administered orally

CpAM (RO7049389)drug

CpAM (RO7049389) will be administered orally

TLR7 (RO7020531)drug

TLR7 (RO7020531) will be administered orally

siRNA (RO7445482)drug

siRNA (RO7445482) will be administered subcutaneously

PEG-IFNdrug

PEG-IFN will be administered subcutaneously

PD-L1 LNA (RO7191863)drug

PD-L1 LNA (RO7191863) will be administered subcutaneously