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NCT01497366 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Sofosbuvir and Ribavirin
A Phase 3 study of Hepatitis C, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 527
- Enrollment target
- 20
- Study locations
NCT01497366: Completed Phase 3 study of Hepatitis C, sponsored by Gilead Sciences.
NCT01497366 is a Phase 3 study of Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 527 participants, below the 1,885-participant average among 106 other Hepatitis C trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497366, a Phase 3 study of Hepatitis C, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 527 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; \< 25 IU/mL) 12 weeks after study drug cessation.
Conditions Studied
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
Study Locations (20)
California
- Franco Felizarta, MD - Bakersfield
- California Liver Institute - Beverly Hills
- Arrowhead Regional Medical Center - Colton
- SCTI Research Foundation - Coronado
- eStudy Site - La Mesa
- Peter J. Ruane, M.D. Inc. - Los Angeles
- eStudySite - Oceanside
- University of California, Davis - Health System - Sacramento
- University of California San Diego Medical Center - San Diego
- Research and Education, Inc. - San Diego
- Medical Associates Research Group, Inc. - San Diego
- Quest Clinical Research - San Francisco
Florida
- Pointe West Infectious Diseases - Bradenton
- Midway Immunology & Research Center, LLC - Ft. Pierce
- University of Florida College of Medicine - Gainesville
- Borland-Groover Clinic Baptist - Jacksonville
- University of Miami, School of Medicine - Miami
Alabama
- University of Alabama at Birmingham - Birmingham
- Alabama Liver & Digestive Specialist - Montgomery
Colorado
- South Denver Gastroenterology, PC - Englewood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 527 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01497366 record still lists
NCT01497366 is an interventional study that assigns participants to a tested intervention. The registered 527 participants enrollment target is mid-sized for trials with a published cap, below the 1,885-participant average among 106 other Hepatitis C trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which RBV is the first listed.
NCT01497366 names 20 study sites across 4 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT01497366 about?
NCT01497366 is a clinical study titled "Phase 3 Study of Sofosbuvir and Ribavirin". This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was ass...
What is the current status of trial NCT01497366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 527 participants. The study started on 2011-12. Estimated completion is 2013-04.
What conditions does trial NCT01497366 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01497366?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG).
Who is sponsoring clinical trial NCT01497366?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01497366 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
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 NCT01497366's enrollment target sits among peer trials
527 19th of 106 higher than 88 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
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