Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety, tolerability and antiviral activity of selgantolimod (formerly GS-9688) in virally suppressed chronic hepatitis B (CHB) adults on oral antiviral (OAV) agents.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Antiviral Agents

Criteria

Key Inclusion Criteria:

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

• Adult males and non-pregnant, non-lactating females

• Documented evidence of chronic HBV infection with detectable hepatitis B surface antigen (HBsAg) levels

• On commercially available HBV OAV treatment(s) for at least 6 months with no change in regimen for 3 months prior to screening

• HBV Deoxyribonucleic acid (DNA) ≤ 20 IU/mL for 6 or more months prior to screening

• Screening Electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

• Extensive bridging fibrosis or cirrhosis

• Adults meeting any of the protocol defined exclusionary laboratory parameters at screening:

• Alanine aminotransferase (ALT) > 3x Upper Limit of Normal (ULN)

• International normalized ratio (INR) > ULN unless the adult is stable on an anticoagulant regimen

• Albumin < 3.5 g/dL

• Direct bilirubin > 1.5x ULN

• Platelet Count < 100,000/uL

• Estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault method)

• Co-infection with human immunodeficiency virus, hepatitis C virus or hepatitis D virus

• Prior history of hepatocellular carcinoma (HCC) or screening alpha-fetoprotein ≥ 50 ng/mL without imaging

• Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease, hemoglobinopathy, retinal disease, or are immunosuppressed.

• Chronic liver disease of a non-HBV etiology, except for non-alcoholic fatty liver disease

• Received solid organ or bone marrow transplant

• Received prolonged therapy with immunomodulators or biologics within 3 months of screening

• Use of another investigational agent within 90 days of screening, unless allowed by the Sponsor

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