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NCT01768286 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 441
- Enrollment target
NCT01768286: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01768286 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 441 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01768286, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 441 participants
- Enrollment target
Study Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
Interventions
- DRUG RBV
- DRUG LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 441 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
What the finished NCT01768286 record still lists
NCT01768286 is an interventional study that assigns participants to a tested intervention. The registered 441 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.
NCT01768286 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01768286 about?
NCT01768286 is a clinical study titled "Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection". This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
What is the current status of trial NCT01768286?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 441 participants. The study started on 2013-01. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01768286?
The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT01768286?
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 NCT01768286's enrollment target sits among peer trials
441 867th of 2000 higher than 1,134 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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