MedTrace Logo

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

NCT04225715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2025-09-19

Study results available
· View outcomes & findings →

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-05
Primary Completion
2024-07-19
Completion
2024-07-19
FDA Drug
Yes

Countries

  • Bulgaria
  • Canada
  • Chile
  • China
  • France
  • Hong Kong
  • New Zealand
  • Romania
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225715 on ClinicalTrials.gov