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NCT01625338 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
A Phase 3 study of Chronic Hepatitis C, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 534
- Enrollment target
- 20
- Study locations
NCT01625338: Completed Phase 3 study of Chronic Hepatitis C, sponsored by Gilead Sciences.
NCT01625338 is a Phase 3 study of Chronic Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 534 participants, above the 181-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (195% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625338, a Phase 3 study of Chronic Hepatitis C, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 534 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Conditions Studied
Interventions
- DRUG SOF
- DRUG RBV
- DRUG Peg-IFN
Study Locations (20)
California
- Franco Felizarta, MD - Bakersfield
- Arrowhead Regional Medical Center - Colton
- Southern California Transplantation Institute, Research Foundation Liver Center - Coronado
- eStudy Site - La Mesa
- Kaiser Permanente - Los Angeles
- Lightsource Medical/Peter J. Ruane MD, Inc. - Los Angeles
- California Liver Institute - Los Angeles
- Anthony Mills MD, Inc. - Los Angeles
- eStudySite - Oceanside
- University of California Davis Medical Center - Sacramento
- University of California - San Diego
- Resarch and Education, Inc. - San Diego
- Medical Associates Research Group - San Diego
- Kaiser Permanente - San Diego
- Quest Clinical Research - San Francisco
Colorado
- University of Colorado Hospital - Aurora
- South Denver Gastroenterology, PC - Englewood
Alabama
- University of Alabama at Birmingham - Birmingham
District of Columbia
- Whitman-Walker Health - Washington D.C.
Florida
- Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases - Bradenton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 534 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01625338 record still lists
NCT01625338 is an interventional study that assigns participants to a tested intervention. The registered 534 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (195% higher).
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which SOF is the first listed.
NCT01625338 names 20 study sites across 5 states, led by California, Colorado, Alabama.
Frequently Asked Questions
What is clinical trial NCT01625338 about?
NCT01625338 is a clinical study titled "Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies". This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved ...
What is the current status of trial NCT01625338?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 534 participants. The study started on 2012-06. Estimated completion is 2014-12.
What conditions does trial NCT01625338 study?
This clinical trial studies the following conditions: Chronic Hepatitis C.
What interventions are being tested in trial NCT01625338?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), Peg-IFN (DRUG).
Who is sponsoring clinical trial NCT01625338?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01625338 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 NCT01625338's enrollment target sits among peer trials
534 3rd of 16 higher than 14 of 16 other Chronic Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic 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.
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