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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: Completed Phase 2 study of Hepatitis C, Chronic, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
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 |
What the finished NCT01435044 record still lists
NCT01435044 is an interventional study that assigns participants to a tested intervention. The registered 239 participants enrollment target is mid-sized for trials with a published cap, below the 367-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (35% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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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 NCT01435044's enrollment target sits among peer trials
239 9th of 26 higher than 18 of 26 other Hepatitis C, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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.
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