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NCT00758043 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 3
Development phase
540
Enrollment target

NCT00758043 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 540 participants.

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The verdict

NCT00758043, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 3
Development phase
540 participants
Enrollment target

Study Summary

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Interventions

  • DRUG ribavirin
  • DRUG telaprevir
  • BIOLOGICAL peginterferon alfa-2a

Trial Details

FieldValue
Enrollment Target 540 participants
Start Date 2008-10
Est. Completion 2010-07
Phase Phase 3

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

What the Registry Record Tells You About NCT00758043

The ClinicalTrials.gov registry entry for NCT00758043 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

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

NCT00758043 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00758043 about?

NCT00758043 is a clinical study titled "A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response". This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative ...

What is the current status of trial NCT00758043?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2008-10. Estimated completion is 2010-07.

What interventions are being tested in trial NCT00758043?

The interventions under investigation include: ribavirin (DRUG), telaprevir (DRUG), peginterferon alfa-2a (BIOLOGICAL).

Who is sponsoring clinical trial NCT00758043?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.

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

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.