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NCT02536313 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target

NCT02536313: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT02536313 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 49 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02536313, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatment experience with a direct acting antiviral (DAA).

Primary Outcome

SVR12 is 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 SOF/VEL/VOX

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2015-07-29
Est. Completion 2016-06-28
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT02536313 record still lists

NCT02536313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (63% lower).

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

NCT02536313 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02536313 about?

NCT02536313 is a clinical study titled "Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen". The primary objective of this study is to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) ± ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection and prior treatme...

What is the current status of trial NCT02536313?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2015-07-29. Estimated completion is 2016-06-28.

What interventions are being tested in trial NCT02536313?

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

Who is sponsoring clinical trial NCT02536313?

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 NCT02536313's enrollment target sits among peer trials

49 1261st of 2000 higher than 736 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 NCT02536313, the US trial registry maintained by the National Library of Medicine. NCT02536313 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.