Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

• Status: Completed
• Trial end date: 2015-03-03
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

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

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

• Currently taking an approved HBV oral antiviral medication

• Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6 months)

• Virally-suppressed (HBV DNA below the lower limit of quantification (LLOQ) for ≥ 1 year)

Key Exclusion Criteria:

• Cirrhosis

• Inadequate liver function

• Co-infection with hepatitic C virus (HCV), HIV or hepatitic D virus (HDV)

• Evidence of hepatocellular carcinoma

• Significant cardiovascular, pulmonary, or neurological disease

• Females who are pregnant or may wish to become pregnant during the study

• Received solid organ or bone marrow transplant

• Use of another investigational agents within 3 months of screening

• Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance

• History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease ulcerative colitis, autoimmune disease

• Known hypersensitivity to study drug, metabolites or formulation excipients

• Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Participants under evaluation for possible malignancy are not eligible.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.