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NCT01641640 · ClinicalTrials.gov registry record · Phase 3
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 328
- Enrollment target
NCT01641640 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 328 participants.
The verdict
NCT01641640, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 328 participants
- Enrollment target
Study Summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Interventions
- DRUG RBV
- DRUG Sofosbuvir
- DRUG PEG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 328 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01641640
The ClinicalTrials.gov registry entry for NCT01641640 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 328 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 3 interventions - of which RBV is the first listed.
NCT01641640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01641640 about?
NCT01641640 is a clinical study titled "Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection". This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks ...
What is the current status of trial NCT01641640?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 328 participants. The study started on 2012-06. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01641640?
The interventions under investigation include: RBV (DRUG), Sofosbuvir (DRUG), PEG (DRUG).
Who is sponsoring clinical trial NCT01641640?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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