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NCT01371578 · ClinicalTrials.gov registry record · Phase 2

Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection

A Phase 2 study, sponsored by Gilead Sciences.

Completed
Registry status
Phase 2
Development phase
163
Enrollment target

NCT01371578: Completed Phase 2 study, sponsored by Gilead Sciences.

NCT01371578 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 163 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01371578, a Phase 2 study, has completed, sponsored by Gilead Sciences.

COMPLETED
Registry status
Phase 2
Development phase
163 participants
Enrollment target

Study Summary

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus (HCV) Infection.

Primary Outcome

To evaluate antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< Lower Limit of Quantification (LLoQ) 24 weeks post-treatment) of response guided therapy (RGT) with GS-9451 + GS-5885, with peginterferon alfa-2a (PEG) and ribavirin (RBV) in treatment-experienced subjects.

Interventions

  • BIOLOGICAL peginterferon alfa-2a
  • DRUG ribavirin tablet
  • DRUG GS-5885 tablet
  • DRUG GS-9451 tablet

Trial Details

FieldValue
Enrollment Target 163 participants
Start Date 2011-07
Est. Completion 2013-03
Phase Phase 2
Gilead Sciences

504 total trials

What the finished NCT01371578 record still lists

NCT01371578 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% higher).

The record links to 0 conditions, and to 4 interventions - of which peginterferon alfa-2a is the first listed.

NCT01371578 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01371578 about?

NCT01371578 is a clinical study titled "Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection". This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus (H...

What is the current status of trial NCT01371578?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 163 participants. The study started on 2011-07. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01371578?

The interventions under investigation include: peginterferon alfa-2a (BIOLOGICAL), ribavirin tablet (DRUG), GS-5885 tablet (DRUG), GS-9451 tablet (DRUG).

Who is sponsoring clinical trial NCT01371578?

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 NCT01371578's enrollment target sits among peer trials

163 418th of 2000 higher than 1,583 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 NCT01371578, the US trial registry maintained by the National Library of Medicine. NCT01371578 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.