NCT02391805

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

A Multiple-Center, Randomized, Partially Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Effects of 12-Week Treatment With RO6864018 in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-05-17
• Primary completion: 2017-10-16
• Completion: 2017-10-16
• First posted: 2015-03-18
• Last updated: 2018-06-06

Locations

14 sites across 6 countries: Hong Kong, Malaysia, New Zealand, Singapore, South Korea, Taiwan