A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection

Location:

Phoenix/Scottsdale, Ariz.

Trial status:
Open for Enrollment
Why is this study being done?

Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments

Who is eligible to participate?

Inclusion Criteria: - Chronic HBV infection for ≥ 6 months - Currently on treatment with at least 1 HBV approved oral drug (i.e. lamivudine, telbivudine, entecavir, adefovir, tenofovir) ≥ 3 months prior to screening - HBsAg ≥ 250 IU/mL - HBV DNA at below the level of quantitation (BLQ; to be confirmed at screening) - Absence of extensive bridging fibrosis (Metavir 3 or greater)or cirrhosis - Creatinine clearance ≥ 70 mL/min Exclusion Criteria: - Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV - History of Gilberts disease - Laboratory parameters not within defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid-stimulating hormone (TSH), or other evidence of hepatic decompensation - Diagnosis of autoimmune disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, or patients who are immunosuppressed - Evidence of hepatocellular carcinoma

Last updated:
9/24/2013
NCT ID:
NCT01590654
IRB Number:
12-005325