At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 178 enrolled
Drug / intervention
GS-4774 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B
In Brief
A Phase 2 clinical trial evaluating GS-4774 and OAV Regimen for Chronic HBV Infection. Completed, enrolled 178 participants across 17 sites in 2 countries.
Detailed Summary
The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic HBV Infection
CountriesNew Zealand, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartSep 2013
First PostedSep 2013
Primary CompletionSep 2014
Study CompletionMar 2015
TodayJul 2026
First PostedSep 17, 2013
Enrollment StartSep 13, 2013
Primary CompletionSep 9, 2014
Study CompletionMar 3, 2015
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 12.8 years ago
Interventions
GS-4774biological
Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
OAV Regimendrug
Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)