A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive 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 either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 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 ≥ 6 months - HBsAg ≥ 250 IU/mL - HBV treatment naïve - 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:
8/8/2013
NCT ID:
NCT01590641
IRB Number:
12-005326