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NCT01590641 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
A Phase 1 study of Hepatitis B and HBV, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 20
- Study locations
NCT01590641: Completed Phase 1 study of Hepatitis B and HBV, sponsored by Gilead Sciences.
NCT01590641 is a Phase 1 study of Hepatitis B and HBV that has completed, run by Gilead Sciences. The registered enrollment target is 49 participants, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01590641, a Phase 1 study of Hepatitis B and HBV, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 20
- Study locations
Study Summary
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
Primary Outcome
Safety will be assessed during the study through the reporting of adverse events, by clinical laboratory tests, physical examinations including vital signs and ECGs at various time points during the study, and by documentation of concomitant medications throughout the study.
Conditions Studied
Interventions
- DRUG Single Ascending Dose (SAD) Cohorts GS-9620
- DRUG Multiple Ascending Dose (MAD) Cohorts
Study Locations (20)
California
- West Coast Clinical Trials, LLC - Costa Mesa
- University of California Antiviral Research Center (AVRC) - San Diego
Alberta
- University of Calgary, Heritage Medical Research Center - Calgary
- University of Alberta Hospital - Edmonton
Arizona
- Mayo Clinic Hospital - Phoenix
Indiana
- Indiana University Medical Center - Indianapolis
Louisiana
- Tulane University Health Sciences Center - New Orleans
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Michigan
- Henry Ford Health System - Detroit
Missouri
- Kansas City Gastroenterology and Hepatology - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 1 |
What the finished NCT01590641 record still lists
NCT01590641 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions - of which Single Ascending Dose (SAD) Cohorts GS-9620 is the first listed.
NCT01590641 names 20 study sites across 18 states, led by California, Alberta, Arizona.
Frequently Asked Questions
What is clinical trial NCT01590641 about?
NCT01590641 is a clinical study titled "A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B". 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 perio...
What is the current status of trial NCT01590641?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2012-04. Estimated completion is 2013-10.
What conditions does trial NCT01590641 study?
This clinical trial studies the following conditions: Hepatitis B, HBV.
What interventions are being tested in trial NCT01590641?
The interventions under investigation include: Single Ascending Dose (SAD) Cohorts GS-9620 (DRUG), Multiple Ascending Dose (MAD) Cohorts (DRUG).
Who is sponsoring clinical trial NCT01590641?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01590641 being conducted?
This trial has 20 study locations across Arizona, California, Indiana, Louisiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01590641's enrollment target sits among peer trials
49 21st of 32 higher than 12 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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