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A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

NCT01516918 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2014-10-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

Conditions

  • Chronic Hepatitis C Virus

Interventions

DRUG

VX-222

tablet, 400-mg twice daily

DRUG

telaprevir

tablet, 1125-mg twice daily

DRUG

ribavirin

tablet, 1000-mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily

BIOLOGICAL

peginterferon-alfa-2a

subcutaneous injection, 180-mcg, once weekly

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Vertex Pharmaceuticals Incorporated

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
2012-02-29
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • 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 NCT01516918 on ClinicalTrials.gov