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VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

NCT01054573 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2013-05-08

Study results available
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Summary

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Telaprevir

750 mg orally every 8 hours (q8h) for 12 weeks

DRUG

pegylated interferon (Peg-IFN) alfa-2a

180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.

DRUG

ribavirin (RBV)

1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.

Sponsors & Collaborators

Principal Investigators

  • Janssen Infectious Diseases BVBA Clinical Trial · Janssen Infectious Diseases BVBA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-03-31
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Netherlands
  • Poland
  • Puerto Rico
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01054573 on ClinicalTrials.gov