A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
This study is currently recruiting participants.
Verified December 2011 by Gilead Sciences
First Received on April 30, 2012. Last Updated on May 2, 2012 History of Changes
Sponsor: | Gilead Sciences |
Information provided by (Responsible Party): | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT01590654 |
Purpose 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
| Condition | Intervention | Phase |
| Hepatitis B | Drug: Single Ascending Dose (SAD) Cohorts GS-9620 Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized |
| Official Title: | 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 |
| 欢迎光临 肝胆相照论坛 (http://hbvhbv.info/forum/) | Powered by Discuz! X1.5 |