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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 278 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01542788
The ClinicalTrials.gov registry entry for NCT01542788 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 278 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.
NCT01542788 reports 0 study locations.
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.
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