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 | Completed Phase 2 DMC

• 1 other identifier: VX11-222-106
• Study Type: interventional
• Target: 103
• Locations: 5 countries
• Sites: 43

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.

Conditions

Chronic Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (7)

• The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.

  up to 48 weeks

• The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)

  24 weeks

• 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

  up to week 12

• 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

  up to 48 weeks

• The association of the IL-28B genotype with SVR12

  12 weeks

Study Arms (1)

Quadruple Regimen

EXPERIMENTAL

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; Drug: telaprevir; Drug: ribavirin; Biological: peginterferon-alfa-2a

Interventions

VX-222 DRUG

tablet, 400-mg twice daily

Quadruple Regimen

telaprevir DRUG

tablet, 1125-mg twice daily

Also known as: Incivek, VX-950, Incivo

Quadruple Regimen

ribavirin DRUG

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

Also known as: Copegus

Quadruple Regimen

peginterferon-alfa-2a BIOLOGICAL

subcutaneous injection, 180-mcg, once weekly

Also known as: Pegasys

Quadruple Regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (43)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Englewood, Colorado, United States

Location

Unknown Facility

Bradenton, Florida, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Marietta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

Egg Harbor, New Jersey, United States

Location

Unknown Facility

Manhasset, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Asheville, North Carolina, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Durham, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Hessen, Germany

Location

Unknown Facility

Saschen, Germany

Location

Unknown Facility

Stuttgart, Germany

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Mysłowice, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Plymouth, United Kingdom

Location

Unknown Facility

Scotland, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

lomibuvir; telaprevir; Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Medical Monitor

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 25, 2012
• Study Start: February 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 20, 2014

Record last verified: 2014-10

Locations

PL (3); US (28); CA (3); DE (6); GB (3)