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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497366
The ClinicalTrials.gov registry entry for NCT01497366 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 527 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,885-participant average among 106 other Hepatitis C trials with a reported enrollment target (72% 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 appearing as the primary indexed condition, and to 3 interventions - of which RBV is the first listed.
NCT01497366 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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