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VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

NCT01241760 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2014-06-04

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Conditions

  • Genotype 1 Chronic Hepatitis C
  • Treatment Naive

Interventions

DRUG

Ribavirin

Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4

DRUG

Telaprevir

1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks

DRUG

Pegylated interferon alfa-2a

180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4

DRUG

Telaprevir

750 mg (2 oral tablets) every 8 hours for 12 weeks

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-08-31
Completion
2012-11-30

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • France
  • Germany
  • Ireland
  • Mexico
  • Poland
  • Spain
  • Sweden
  • 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 NCT01241760 on ClinicalTrials.gov