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NCT02639338 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis

A Phase 3 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 3
Development phase
220
Enrollment target

NCT02639338: Completed Phase 3 study, sponsored by Gilead Sciences.

NCT02639338 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 220 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02639338, a Phase 3 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 3
Development phase
220 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

Primary Outcome

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Interventions

  • DRUG SOF/VEL/VOX
  • DRUG SOF/VEL

Trial Details

FieldValue
Enrollment Target 220 participants
Start Date 2015-12-23
Est. Completion 2017-01-02
Phase Phase 3
Gilead Sciences

504 total trials

What the finished NCT02639338 record still lists

NCT02639338 is an interventional study that assigns participants to a tested intervention. The registered 220 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 (72% lower).

The record links to 0 conditions, and to 2 interventions - of which SOF/VEL/VOX is the first listed.

NCT02639338 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02639338 about?

NCT02639338 is a clinical study titled "Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis". The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to dire...

What is the current status of trial NCT02639338?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 220 participants. The study started on 2015-12-23. Estimated completion is 2017-01-02.

What interventions are being tested in trial NCT02639338?

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

Who is sponsoring clinical trial NCT02639338?

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 NCT02639338's enrollment target sits among peer trials

220 1318th of 2000 higher than 672 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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Source: ClinicalTrials.gov NCT02639338, the US trial registry maintained by the National Library of Medicine. NCT02639338 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.