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NCT01356160 · ClinicalTrials.gov registry record · Phase 2
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
A Phase 2 study of Hepatitis C, Chronic, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 351
- Enrollment target
- 20
- Study locations
NCT01356160: Completed Phase 2 study of Hepatitis C, Chronic, sponsored by Gilead Sciences.
NCT01356160 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by Gilead Sciences. The registered enrollment target is 351 participants, roughly in line with the 363-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01356160, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 351 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
Primary Outcome
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA \< Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Conditions Studied
Interventions
- DRUG GS-5885
- DRUG GS-9451
- BIOLOGICAL peginterferon alfa-2a
- DRUG ribavirin tablet
- DRUG GS-9451 Placebo
Study Locations (20)
California
- - Beverly Hills
- - Coronado
- - Costa Mesa
- - San Diego
Texas
- - Arlington
- - Houston
- - San Antonio
Colorado
- - Aurora
- - Englewood
Maryland
- - Baltimore
- - Baltimore
New York
- - Forest Hills
- - Manhasset
Arizona
- - Tucson
Florida
- - Bradenton
Massachusetts
- - Burlington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01356160 record still lists
NCT01356160 is an interventional study that assigns participants to a tested intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 363-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target.
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 5 interventions - of which GS-5885 is the first listed.
NCT01356160 names 20 study sites across 12 states, led by California, Texas, Colorado.
Frequently Asked Questions
What is clinical trial NCT01356160 about?
NCT01356160 is a clinical study titled "GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus". This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.
What is the current status of trial NCT01356160?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 351 participants. The study started on 2011-07. Estimated completion is 2013-06.
What conditions does trial NCT01356160 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT01356160?
The interventions under investigation include: GS-5885 (DRUG), GS-9451 (DRUG), peginterferon alfa-2a (BIOLOGICAL), ribavirin tablet (DRUG), GS-9451 Placebo (DRUG).
Who is sponsoring clinical trial NCT01356160?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01356160 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C, Chronic
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 NCT01356160's enrollment target sits among peer trials
351 6th of 26 higher than 21 of 26 other Hepatitis C, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C, Chronic 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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