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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

Primary Purpose

Chronic Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VX-222
telaprevir
ribavirin
peginterferon-alfa-2a
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must have compensated cirrhosis
  • Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
  • Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion Criteria:

  • Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
  • Any contraindication to Peg-IFN or RBV therapy
  • Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
  • A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quadruple Regimen

Arm Description

All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.

Outcomes

Primary Outcome Measures

The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)

Secondary Outcome Measures

The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment
The association of the IL-28B genotype with SVR12
Proportion of subjects who have SVR12 by IL-28B genotype
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations

Full Information

First Posted
January 13, 2012
Last Updated
October 9, 2014
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01516918
Brief Title
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
Official Title
A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadruple Regimen
Arm Type
Experimental
Arm Description
All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
Intervention Type
Drug
Intervention Name(s)
VX-222
Intervention Description
tablet, 400-mg twice daily
Intervention Type
Drug
Intervention Name(s)
telaprevir
Other Intervention Name(s)
Incivek, VX-950, Incivo
Intervention Description
tablet, 1125-mg twice daily
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
Intervention Type
Biological
Intervention Name(s)
peginterferon-alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
subcutaneous injection, 180-mcg, once weekly
Primary Outcome Measure Information:
Title
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Time Frame
up to 48 weeks
Title
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Time Frame
24 weeks
Title
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment
Time Frame
up to week 12
Title
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment
Time Frame
up to 48 weeks
Title
The association of the IL-28B genotype with SVR12
Description
Proportion of subjects who have SVR12 by IL-28B genotype
Time Frame
12 weeks
Title
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
Description
The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
Time Frame
After the last planned dose of study drug or after time of failure
Title
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must have genotype 1 Chronic Hepatitis C Subjects must have compensated cirrhosis Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered Subjects with hemophilia may be permitted to enroll with permission of the medical monitor Exclusion Criteria: Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor Any contraindication to Peg-IFN or RBV therapy Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Bradenton
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Lebanon
State/Province
New Hampshire
Country
United States
City
Egg Harbor Township
State/Province
New Jersey
Country
United States
City
Manhasset
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Arlington
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States
City
Vancouver
State/Province
British Columbia
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
City
Hessen
Country
Germany
City
Koeln
Country
Germany
City
Saschen
Country
Germany
City
Stuttgart
Country
Germany
City
Bialystok
Country
Poland
City
Myslowice
Country
Poland
City
Wroclaw
Country
Poland
City
London
Country
United Kingdom
City
Plymouth
Country
United Kingdom
City
Scotland
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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