Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment

• Status: Completed
• Trial end date: 2021-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB) who are viremic and not currently being treated.

• 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 male and non-pregnant, non-lactating females

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

• Screening HBV deoxyribonucleic acid (DNA) ≥ 2000 IU/mL.

• Screening electrocardiogram (ECG) without clinically significant abnormalities

Key Exclusion Criteria:

• Extensive bridging fibrosis or cirrhosis

• Received a commercially available HBV OAV treatment(s) within the 3 months prior to screening.

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

• Individuals meeting any of the following laboratory parameters at screening:

• Alanine aminotransferase > 5 * upper limit of normal (ULN)

• International normalized ratio > ULN unless the individual is stable on an anticoagulant regimen

• Albumin < 3.5 g/dL

• Direct bilirubin >1.5x ULN

• Platelet Count < 100,000/µL

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

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

• Prior history of hepatocellular carcinoma 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.

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

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