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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 202 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01604850
The ClinicalTrials.gov registry entry for NCT01604850 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which SOF is the first listed.
NCT01604850 reports 0 study locations.
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.
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