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NCT01641640 · ClinicalTrials.gov registry record · Phase 3
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
NCT01641640: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01641640 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 328 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641640, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
Study Summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
What the finished NCT01641640 record still lists
NCT01641640 is an interventional study that assigns participants to a tested intervention. The registered 328 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 3 interventions - of which RBV is the first listed.
NCT01641640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641640 about?
NCT01641640 is a clinical study titled "Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection". This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks ...
What is the current status of trial NCT01641640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2012-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01641640?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG).
Who is sponsoring clinical trial NCT01641640?
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 NCT01641640's enrollment target sits among peer trials
328 1074th of 2000 higher than 926 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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