A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: Ribavirin; Drug: Telaprevir; Drug: Pegylated interferon alfa 2a

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary Medical Clinic
    • Edmonton, Alberta, Canada
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia Vancouver General Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada
  • Ontario
    • Toronto, Ontario, Canada
• France
  • Creteil, France
    • Hospital Henri Mondor
  • Lyon, France
  • Nice, France
  • Paris, France
  • Pessac, France
  • Vandoeuvre, France
• Germany
  • Berlin, Germany
  • Bonn, Germany
    • Universitätsklinikum Bonn
  • Cologne, Germany
    • University of Cologne
  • Dusseldorf, Germany, 40225
    • Uniklinik Duesseldorf
  • Frankfurt, Germany
  • Hannover, Germany
• Netherlands
  • Amsterdam, Netherlands
    • Academic Medical Center
  • Leiden, Netherlands
    • Leiden University Medical Center
  • Rotterdam, Netherlands
    • Erasmus MC Medical Center
• Puerto Rico
  • Santurce, Puerto Rico
    • Fundacion de Investigation de Diego
• United Kingdom
  • London, United Kingdom
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • California
    • Los Angeles, California, United States
    • San Diego, California, United States
      • Kaiser Permanente Internal Medicine
    • San Francisco, California, United States
  • Colorado
    • Denver, Colorado, United States
      • University of Colorado Health Sciences Center
    • Englewood, Colorado, United States
      • South Denver Gastroenterology
  • Florida
    • Gainesville, Florida, United States
      • University of Florida
    • Jacksonville, Florida, United States
      • Borland-Groover Clinic
    • Jacksonville, Florida, United States
      • Mayo Clinic Jacksonville
    • Miami, Florida, United States
      • University of Miami Center for Liver Diseases
    • Sarasota, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
      • Atlanta Gastroenterology Associates
  • Illinois
    • Chicago, Illinois, United States
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Digestive and Liver Disease Clinic
  • Maine
    • Portland, Maine, United States
      • Virology Treatment Center, Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States
      • Beth Israel Deaconess Medical Center
    • Worcester, Massachusetts, United States
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Detroit, Michigan, United States
      • Henry Ford Hospital
  • Missouri
    • St Louis, Missouri, United States
      • St Louis University
  • Nebraska
    • Omaha, Nebraska, United States
      • The Nebraska Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico
  • New York
    • Manhasset, New York, United States
      • North Shore University Hospital
    • New York, New York, United States
  • North Carolina
    • Durham, North Carolina, United States
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States
      • University of Cincinnati
    • Cleveland, Ohio, United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States
      • Penn State Hershey Medical Center
    • Pittsburgh, Pennsylvania, United States
      • University of Pittsburgh Medical Center
  • South Carolina
    • Columbia, South Carolina, United States
      • Columbia Gastroenterology Associates, PA
  • Tennessee
    • Germantown, Tennessee, United States
      • Memphis Gastroenterology Group
  • Texas
    • Dallas, Texas, United States
      • Liver Institute at Methodist Dallas
    • Houston, Texas, United States
    • San Antonio, Texas, United States
      • Alamo Medical Research
  • Virginia
    • Annandale, Virginia, United States
    • Charlottesville, Virginia, United States
      • University of Virginia Health Systems
    • Fairfax, Virginia, United States
      • Metropolitan Research
    • Richmond, Virginia, United States
      • McGuire DVAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week; Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.	Drug: Ribavirin; Tablet; Drug: Telaprevir; Tablet; Other Names: VX-950; Drug: Pegylated interferon alfa 2a; Solution for Injection
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week; Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.	Drug: Ribavirin; Tablet; Drug: Telaprevir; Tablet; Other Names: VX-950; Drug: Pegylated interferon alfa 2a; Solution for Injection
Experimental: Other; Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.	Drug: Ribavirin; Tablet; Drug: Telaprevir; Tablet; Other Names: VX-950; Drug: Pegylated interferon alfa 2a; Solution for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.	Baseline through Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Prior Relapsers With Undetectable HCV RNA	Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response	Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response	Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.	Baseline up to Week 72

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborators: Tibotec, Inc
• Investigators: Study Director: Nathalie Adda, MD, Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 25, 2007
• First Submitted That Met QC Criteria: September 25, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): August 5, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Genotype 1
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Interferons; Interferon-alpha; Ribavirin; Peginterferon alfa-2a; Interferon alpha-2
• Other Study ID Numbers: VX06-950-107