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NCT02120300 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
122
Enrollment target

NCT02120300: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT02120300 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 122 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02120300, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
122 participants
Enrollment target

Study Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in participants with genotypes 2 and 3 HCV infection. Participants with an inherited bleeding disorder and chronic HCV infection (either monoinfected or HIV-1/HCV coinfected) will be enrolled.

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 SOF
  • DRUG RBV
  • DRUG LDV/SOF

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2014-04
Est. Completion 2015-08
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT02120300 record still lists

NCT02120300 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which SOF is the first listed.

NCT02120300 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02120300 about?

NCT02120300 is a clinical study titled "Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders". The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with genotypes 1 and 4 hepatitis C virus (HCV) infection and sofosbuvir (SOF) plus ribavirin (RBV) in p...

What is the current status of trial NCT02120300?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2014-04. Estimated completion is 2015-08.

What interventions are being tested in trial NCT02120300?

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

Who is sponsoring clinical trial NCT02120300?

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 NCT02120300's enrollment target sits among peer trials

122 565th of 2000 higher than 1,434 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 NCT02120300, the US trial registry maintained by the National Library of Medicine. NCT02120300 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.