MedTrace Logo

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

NCT01459913 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 239

Last updated 2015-06-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Telaprevir

Tablet

DRUG

Pegylated Interferon Alfa-2a

Subcutaneous Injection

DRUG

Ribavirin

Tablet

Sponsors & Collaborators

Principal Investigators

  • Mark Friedman, M.D. · Vertex Pharmaceuticals Incorporated

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
2011-11-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States
  • Austria
  • Canada
  • Germany
  • Israel
  • Poland

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 NCT01459913 on ClinicalTrials.gov