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NCT01701401 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 870
- Enrollment target
NCT01701401: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01701401 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 870 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701401, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 870 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
Primary Outcome
SVR12 was defined as HCV RNA level \< the lower limit of quantification (LLOQ, ie, \< 25 copies/mL) 12 weeks after last dose of study drug.
Interventions
- DRUG RBV
- DRUG LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2012-09 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01701401 record still lists
NCT01701401 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.
NCT01701401 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701401 about?
NCT01701401 is a clinical study titled "Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV". The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
What is the current status of trial NCT01701401?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 870 participants. The study started on 2012-09. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01701401?
The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT01701401?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701401's enrollment target sits among peer trials
870 373rd of 2000 higher than 1,627 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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