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NCT01329978 · ClinicalTrials.gov registry record · Phase 2
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 332
- Enrollment target
NCT01329978: Completed Phase 2 study, sponsored by Gilead Sciences.
NCT01329978 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 332 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01329978, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 332 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
Primary Outcome
SVR24 was defined as HCV RNA \< the limit of detection (LOD; \< 15 IU/mL) 24 weeks after the last dose of study drug.
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 332 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT01329978 record still lists
NCT01329978 is an interventional study that assigns participants to a tested intervention. The registered 332 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (150% higher).
The record links to 0 conditions, and to 3 interventions - of which RBV is the first listed.
NCT01329978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01329978 about?
NCT01329978 is a clinical study titled "Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6". The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.
What is the current status of trial NCT01329978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 332 participants. The study started on 2011-03. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01329978?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG).
Who is sponsoring clinical trial NCT01329978?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01329978's enrollment target sits among peer trials
332 144th of 2000 higher than 1,856 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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