Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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

NCT00535847 · View on ClinicalTrials.gov ↗

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

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 82 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00535847 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00535847?

The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Pegylated interferon alfa 2a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00535847?

This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 82 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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