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NCT01188772 · ClinicalTrials.gov registry record · Phase 2
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT01188772 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 147 participants.
The verdict
NCT01188772, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
- DRUG Placebo to match sofosbuvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01188772
The ClinicalTrials.gov registry entry for NCT01188772 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 147 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 RBV is the first listed.
NCT01188772 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01188772 about?
NCT01188772 is a clinical study titled "Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients". Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Ran...
What is the current status of trial NCT01188772?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2010-08. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01188772?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG), Placebo to match sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT01188772?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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