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NCT01962441 · ClinicalTrials.gov registry record · Phase 3
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
A Phase 3 study of Hepatitis C, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
- 20
- Study locations
NCT01962441 is a Phase 3 study of Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 601 participants, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01962441, a Phase 3 study of Hepatitis C, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.
Conditions Studied
Interventions
- DRUG SOF
- DRUG RBV
- DRUG Peg-IFN
Study Locations (20)
California
- - Riverside
- - San Diego
- - San Francisco
Tennessee
- - Germantown
- - Nashville
- - Nashville
Colorado
- - Aurora
- - Englewood
Florida
- - Miami
- - Wellington
New Jersey
- - Hillsborough
- - Newark
New York
- - Binghamton
- - New York
Georgia
- - Marietta
Louisiana
- - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2013-09-24 |
| Est. Completion | 2016-07-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962441
The ClinicalTrials.gov registry entry for NCT01962441 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 601 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,884-participant average among 106 other Hepatitis C trials with a reported enrollment target (68% 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 SOF is the first listed.
NCT01962441 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Tennessee, Colorado.
Frequently Asked Questions
What is clinical trial NCT01962441 about?
NCT01962441 is a clinical study titled "SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection". This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and ...
What is the current status of trial NCT01962441?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2013-09-24. Estimated completion is 2016-07-07.
What conditions does trial NCT01962441 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01962441?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), Peg-IFN (DRUG).
Who is sponsoring clinical trial NCT01962441?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01962441 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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