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NCT00535847 · ClinicalTrials.gov registry record · Phase 2

A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

A Phase 2 study of Hepatitis C, sponsored by Vertex Pharmaceuticals Incorporated.

Completed
Registry status
Phase 2
Development phase
117
Enrollment target
20
Study locations

NCT00535847 is a Phase 2 study of Hepatitis C that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 117 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00535847, a Phase 2 study of Hepatitis C, has completed, sponsored by Vertex Pharmaceuticals Incorporated.

COMPLETED
Registry status
Phase 2
Development phase
117 participants
Enrollment target
20
Study locations

Study Summary

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Conditions Studied

Hepatitis C

Interventions

  • DRUG Ribavirin
  • DRUG Telaprevir
  • DRUG Pegylated interferon alfa 2a

Study Locations (20)

Florida

  • University of Florida - Gainesville
  • Borland-Groover Clinic - Jacksonville
  • Mayo Clinic Jacksonville - Jacksonville
  • University of Miami Center for Liver Diseases - Miami
  • - Sarasota

California

  • - Los Angeles
  • Kaiser Permanente Internal Medicine - San Diego
  • - San Francisco

Colorado

  • University of Colorado Health Sciences Center - Denver
  • South Denver Gastroenterology - Englewood

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston
  • University of Massachusetts Memorial Medical Center - Worcester

Alabama

  • - Birmingham

Georgia

  • Atlanta Gastroenterology Associates - Atlanta

Illinois

  • University of Chicago - Chicago

Indiana

  • - Indianapolis

Trial Details

FieldValue
Enrollment Target 117 participants
Start Date 2007-10
Est. Completion 2010-02
Phase Phase 2

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00535847

The ClinicalTrials.gov registry entry for NCT00535847 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (94% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.

NCT00535847 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00535847 about?

NCT00535847 is a clinical study titled "A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy". To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonu...

What is the current status of trial NCT00535847?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2007-10. Estimated completion is 2010-02.

What conditions does trial NCT00535847 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT00535847?

The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Pegylated interferon alfa 2a (DRUG).

Who is sponsoring clinical trial NCT00535847?

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

Where is trial NCT00535847 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.