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A Study of Treatment With RO6864018 in Virologically Suppressed Participants With Chronic Hepatitis B Virus (HBV) Infection

NCT02391805 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-06-06

No results posted yet for this study

Summary

This randomized, multicenter, partially double-blind, placebo-controlled study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antiviral effects of treatment with RO6864018 in virologically suppressed participants with chronic HBV infection.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Entecavir

Entecavir will be administered as per local labeling.

DRUG

Placebo

Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.

DRUG

RO6864018

Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.

DRUG

Tenofovir

Tenofovir will be administered as per local labeling.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-05-17
Primary Completion
2017-10-16
Completion
2017-10-16

Countries

  • Hong Kong
  • Malaysia
  • New Zealand
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
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 NCT02391805 on ClinicalTrials.gov