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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01516918
First received: January 13, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Virus
Drug: VX-222
Drug: telaprevir
Drug: ribavirin
Biological: peginterferon-alfa-2a
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]
  • The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The association of the IL-28B genotype with SVR12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: After the last planned dose of study drug or after time of failure ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Quadruple Regimen
All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks.
Drug: VX-222
tablet, 400-mg twice daily
Drug: telaprevir
tablet, 1125-mg twice daily
Other Name: Incivek, VX-950, Incivo
Drug: ribavirin
tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
Other Name: Copegus
Biological: peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Other Name: Pegasys

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516918

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
San Diego, California, United States
United States, Colorado
Englewood, Colorado, United States
United States, Florida
Bradenton, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New Jersey
Egg Harbor Township, New Jersey, United States
United States, New York
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
United States, North Carolina
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Germantown, Tennessee, United States
United States, Texas
Arlington, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Germany
Hamburg, Germany
Heidelberg, Germany
Hessen, Germany
Koeln, Germany
Saschen, Germany
Stuttgart, Germany
Poland
Bialystok, Poland
Myslowice, Poland
Wroclaw, Poland
United Kingdom
London, United Kingdom
Plymouth, United Kingdom
Scotland, United Kingdom
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01516918     History of Changes
Other Study ID Numbers: VX11-222-106
Study First Received: January 13, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Fibrosis
Hepatitis C, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014