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NCT01384383 · ClinicalTrials.gov registry record · Phase 2

GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

A Phase 2 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 2
Development phase
248
Enrollment target

NCT01384383 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 248 participants.

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The verdict

NCT01384383, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 2
Development phase
248 participants
Enrollment target

Study Summary

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.

Interventions

  • DRUG RBV
  • DRUG PEG
  • DRUG GS-5885
  • DRUG GS-9451

Trial Details

FieldValue
Enrollment Target 248 participants
Start Date 2011-08
Est. Completion 2013-06
Phase Phase 2

Sponsor

Gilead Sciences

504 total trials

What the Registry Record Tells You About NCT01384383

The ClinicalTrials.gov registry entry for NCT01384383 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 248 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which RBV is the first listed.

NCT01384383 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01384383 about?

NCT01384383 is a clinical study titled "GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype". This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjec...

What is the current status of trial NCT01384383?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 248 participants. The study started on 2011-08. Estimated completion is 2013-06.

What interventions are being tested in trial NCT01384383?

The interventions under investigation include: RBV (DRUG), PEG (DRUG), GS-5885 (DRUG), GS-9451 (DRUG).

Who is sponsoring clinical trial NCT01384383?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.