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

• Status: Completed
• Trial end date: 2017-10-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Entecavir; Tenofovir

Criteria

Inclusion Criteria:

• Chronic hepatitis B infection

• Positive test for HBsAg for more than 6 months prior to randomization

• HBsAg titer greater than or equal to (>/=) 250 international units per milliliter (IU/mL) at Screening

• Treatment with any nucleoside/nucleotide analogue for >/= 1 year with ongoing entecavir and/or tenofovir treatment at randomization and for at least 3 months prior to randomization

• HBV DNA less than (<) 90 IU/mL for at least the preceding 6 months

• HBeAg positive at randomization and for at least 6 months prior to randomization

Exclusion Criteria:

• Pregnant or lactating women

• Documented history of HBV genotype D

• History or other evidence of bleeding from esophageal varices

• History of decompensated liver disease, chronic liver disease other than HBV infection, or any evidence of metabolic liver disease

• Positive test for hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)

• Documented history of hepatitis D infection

• History of or suspicion of hepatocellular carcinoma

• History of immunologically mediated disease

• History of organ transplantation

• History of thyroid disease

• Significant acute infection