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NCT01604850 · ClinicalTrials.gov registry record · Phase 3
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
NCT01604850: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01604850 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 202 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01604850, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 202 participants
- Enrollment target
Study Summary
This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic 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. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Interventions
- DRUG SOF
- DRUG RBV
- DRUG Placebo to match SOF
- DRUG Placebo to match RBV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-05 |
| Phase | Phase 3 |
What the finished NCT01604850 record still lists
NCT01604850 is an interventional study that assigns participants to a tested intervention. The registered 202 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 (74% lower).
The record links to 0 conditions, and to 4 interventions - of which SOF is the first listed.
NCT01604850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01604850 about?
NCT01604850 is a clinical study titled "Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)". This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks af...
What is the current status of trial NCT01604850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2012-06. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01604850?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), Placebo to match SOF (DRUG), Placebo to match RBV (DRUG).
Who is sponsoring clinical trial NCT01604850?
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 NCT01604850's enrollment target sits among peer trials
202 1353rd of 2000 higher than 648 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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