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NCT01726517 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
100
Enrollment target

NCT01726517: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT01726517 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01726517, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study Summary

This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.

Primary Outcome

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.

Interventions

  • DRUG RBV
  • DRUG LDV/SOF

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2012-10
Est. Completion 2014-01
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT01726517 record still lists

NCT01726517 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 2 interventions - of which RBV is the first listed.

NCT01726517 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01726517 about?

NCT01726517 is a clinical study titled "Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects". This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are tr...

What is the current status of trial NCT01726517?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2012-10. Estimated completion is 2014-01.

What interventions are being tested in trial NCT01726517?

The interventions under investigation include: RBV (DRUG), LDV/SOF (DRUG).

Who is sponsoring clinical trial NCT01726517?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01726517's enrollment target sits among peer trials

100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01726517, the US trial registry maintained by the National Library of Medicine. NCT01726517 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.