Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adults With Chronic Hepatitis B
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/6/2019 |
Start Date: | April 6, 2018 |
End Date: | February 2020 |
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety, Tolerability and Antiviral Activity of GS-9688 in Virally-Suppressed Adult Subjects With Chronic Hepatitis B
The primary objectives of this study are to evaluate the safety, tolerability and antiviral
activity of multiple oral doses of GS-9688 in virally suppressed chronic hepatitis B (CHB)
adults on oral antiviral (OAV) agents.
activity of multiple oral doses of GS-9688 in virally suppressed chronic hepatitis B (CHB)
adults on oral antiviral (OAV) agents.
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 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.
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials