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NCT02128542 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
A Phase 4 study of Hepatitis C Virus Infection, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
- 17
- Study locations
NCT02128542: Completed Phase 4 study of Hepatitis C Virus Infection, sponsored by Gilead Sciences.
NCT02128542 is a Phase 4 study of Hepatitis C Virus Infection that has completed, run by Gilead Sciences. The registered enrollment target is 66 participants, below the 189-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (65% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02128542, a Phase 4 study of Hepatitis C Virus Infection, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.
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 RBV
- DRUG Sofosbuvir
Study Locations (17)
California
- - Long Beach
- - Los Angeles
- - Palo Alto
- - San Diego
- - San Francisco
Pennsylvania
- - Philadelphia
- - Pittsburgh
Texas
- - Dallas
- - Houston
Connecticut
- - New Haven
Florida
- - Miami
Georgia
- - Decatur
Maryland
- - Baltimore
Missouri
- - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-06 |
| Phase | Phase 4 |
What the finished NCT02128542 record still lists
NCT02128542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 189-participant average among 5 other Hepatitis C Virus Infection trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Hepatitis C Virus Infection appearing as the primary indexed condition, and to 2 interventions - of which RBV is the first listed.
NCT02128542 lists 17 locations in 11 states (California, Pennsylvania, Texas).
Frequently Asked Questions
What is clinical trial NCT02128542 about?
NCT02128542 is a clinical study titled "Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis". This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.
What is the current status of trial NCT02128542?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2014-06. Estimated completion is 2015-06.
What conditions does trial NCT02128542 study?
This clinical trial studies the following conditions: Hepatitis C Virus Infection.
What interventions are being tested in trial NCT02128542?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT02128542?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02128542 being conducted?
This trial has 17 study locations across California, Connecticut, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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