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NCT02631772 · ClinicalTrials.gov registry record · Phase 4

LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

A Phase 4 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 4
Development phase
32
Enrollment target

NCT02631772: Completed Phase 4 study, sponsored by Medical University of South Carolina.

NCT02631772 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 32 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02631772, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 4
Development phase
32 participants
Enrollment target

Study Summary

The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

Primary Outcome

Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen

Interventions

  • DRUG Sofosbuvir/Ledipasvir x 12 weeks
  • DRUG Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-06-01
Est. Completion 2018-06-30
Phase Phase 4

What the finished NCT02631772 record still lists

NCT02631772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Sofosbuvir/Ledipasvir x 12 weeks is the first listed.

NCT02631772 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02631772 about?

NCT02631772 is a clinical study titled "LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients". The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim ...

What is the current status of trial NCT02631772?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 32 participants. The study started on 2016-06-01. Estimated completion is 2018-06-30.

What interventions are being tested in trial NCT02631772?

The interventions under investigation include: Sofosbuvir/Ledipasvir x 12 weeks (DRUG), Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks (DRUG).

Who is sponsoring clinical trial NCT02631772?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02631772's enrollment target sits among peer trials

32 1534th of 2000 higher than 457 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT02631772, the US trial registry maintained by the National Library of Medicine. NCT02631772 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.