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NCT01542788 · ClinicalTrials.gov registry record · Phase 3
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 278
- Enrollment target
NCT01542788: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01542788 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 278 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01542788, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 278 participants
- Enrollment target
Study Summary
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
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 SOF
- DRUG RBV
- DRUG Placebo to match SOF
- DRUG Placebo to match RBV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2012-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01542788 record still lists
NCT01542788 is an interventional study that assigns participants to a tested intervention. The registered 278 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 (64% lower).
The record links to 0 conditions, and to 4 interventions - of which SOF is the first listed.
NCT01542788 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01542788 about?
NCT01542788 is a clinical study titled "Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon". This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match ...
What is the current status of trial NCT01542788?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2012-03. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01542788?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), Placebo to match SOF (DRUG), Placebo to match RBV (DRUG).
Who is sponsoring clinical trial NCT01542788?
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 NCT01542788's enrollment target sits among peer trials
278 1200th of 2000 higher than 799 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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