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NCT01435044 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
A Phase 2 study of Hepatitis C, Chronic, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 239
- Enrollment target
- 20
- Study locations
NCT01435044 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by Gilead Sciences. The registered enrollment target is 239 participants, below the 367-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT01435044, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 239 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).
Conditions Studied
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG GS-0938
- DRUG Placebo to match sofosbuvir
- DRUG Placebo to match GS-0938
Study Locations (20)
California
- - Bakersfield
- - Coronado
- - La Mesa
- - Los Angeles
- CLI - Los Angeles
- UCSD Antiviral Research Center - San Diego
- eStudy Site - San Diego
- Medical Associates Research Group - San Diego
- Quest Clinical Research - San Francisco
Florida
- Avail Clinical Research - DeLand
- University of Florida Hepatology - Gainesville
- University of Miami Center for Liver Diseases - Miami
- Orlando Immunology Center - Orlando
- Internal Medicine Specialists - Orlando
- Miami Research Associates - South Miami
Colorado
- - Denver
- - Engelwood
- South Denver Gastroenterology - Englewood
Alabama
- Alabama Liver & Digestive Specialists - Montgomery
District of Columbia
- - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 239 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01435044
The ClinicalTrials.gov registry entry for NCT01435044 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 239 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 367-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (35% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 5 interventions - of which RBV is the first listed.
NCT01435044 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT01435044 about?
NCT01435044 is a clinical study titled "Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection". This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify ...
What is the current status of trial NCT01435044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 239 participants. The study started on 2011-09. Estimated completion is 2013-05.
What conditions does trial NCT01435044 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT01435044?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), GS-0938 (DRUG), Placebo to match sofosbuvir (DRUG), Placebo to match GS-0938 (DRUG).
Who is sponsoring clinical trial NCT01435044?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01435044 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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