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NCT01054729 · ClinicalTrials.gov registry record · Phase 2
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01054729 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 64 participants.
The verdict
NCT01054729, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.
Interventions
- DRUG Placebo
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01054729
The ClinicalTrials.gov registry entry for NCT01054729 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 64 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 Placebo is the first listed.
NCT01054729 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01054729 about?
NCT01054729 is a clinical study titled "Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients". Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo t...
What is the current status of trial NCT01054729?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2010-01. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01054729?
The interventions under investigation include: Placebo (DRUG), RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG).
Who is sponsoring clinical trial NCT01054729?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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