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NCT02600351 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
A Phase 3 study, sponsored by Gilead Sciences.
- Terminated
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT02600351: Clinical Trial Phase 3 study, sponsored by Gilead Sciences.
NCT02600351 is a Phase 3 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02600351, a Phase 3 study, was terminated before completion, sponsored by Gilead Sciences.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
Primary Outcome
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 15 IU/mL) at 12 weeks after stopping study treatment.
Interventions
- DRUG RBV
- DRUG LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2015-11-11 |
| Est. Completion | 2017-05-29 |
| Phase | Phase 3 |
Why NCT02600351 stopped before completion
NCT02600351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.
NCT02600351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02600351 about?
NCT02600351 is a clinical study titled "Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies". The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks ...
What is the current status of trial NCT02600351?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2015-11-11. Estimated completion is 2017-05-29.
What interventions are being tested in trial NCT02600351?
The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT02600351?
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 NCT02600351's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 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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