A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hep

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    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 Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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