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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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Ribavirin
Pegylated interferon alfa 2a
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Genotype 1

Eligibility Criteria

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

Inclusion Criteria:

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

Sites / Locations

  • Kaiser Permanente Internal Medicine
  • University of Colorado Health Sciences Center
  • South Denver Gastroenterology
  • University of Florida
  • Borland-Groover Clinic
  • Mayo Clinic Jacksonville
  • University of Miami Center for Liver Diseases
  • Atlanta Gastroenterology Associates
  • University of Chicago
  • Digestive and Liver Disease Clinic
  • Virology Treatment Center, Maine Medical Center
  • Johns Hopkins University
  • Beth Israel Deaconess Medical Center
  • University of Massachusetts Memorial Medical Center
  • Henry Ford Hospital
  • St Louis University
  • The Nebraska Medical Center
  • University of New Mexico
  • North Shore University Hospital
  • Duke University Medical Center
  • University of Cincinnati
  • Penn State Hershey Medical Center
  • University of Pittsburgh Medical Center
  • Columbia Gastroenterology Associates, PA
  • Memphis Gastroenterology Group
  • Liver Institute at Methodist Dallas
  • Alamo Medical Research
  • University of Virginia Health Systems
  • Metropolitan Research
  • McGuire DVAMC
  • University of Calgary Medical Clinic
  • University of Alberta
  • University of British Columbia Vancouver General Hospital
  • Hospital Henri Mondor
  • Universitatsklinikum Bonn
  • University of Cologne
  • Uniklinik Duesseldorf
  • Academic Medical Center
  • Leiden University Medical Center
  • Erasmus MC Medical Center
  • Fundacion de Investigation de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week

Other

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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).
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).
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).
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.

Full Information

First Posted
September 25, 2007
Last Updated
July 9, 2014
Sponsor
Vertex Pharmaceuticals Incorporated
Collaborators
Tibotec, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00535847
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Genotype 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Arm Type
Experimental
Arm Description
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.
Arm Title
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Arm Type
Experimental
Arm Description
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.
Arm Title
Other
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
VX-950
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alfa 2a
Intervention Description
Solution for Injection
Primary Outcome Measure Information:
Title
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Description
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).
Time Frame
24 weeks after the completion of treatment (up to Week 72)
Title
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline through Week 48
Secondary Outcome Measure Information:
Title
Percentage of Prior Relapsers With Undetectable HCV RNA
Description
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).
Time Frame
24 weeks after the completion of treatment (up to Week 72)
Title
Percentage of Subjects With End of Treatment Response
Description
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).
Time Frame
End of treatment (up to Week 48)
Title
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Description
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).
Time Frame
48 weeks after completion of treatment (up to Week 96)
Title
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Description
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.
Time Frame
Baseline up to Week 72

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: Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Adda, MD
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Kaiser Permanente Internal Medicine
City
San Diego
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
University of Miami Center for Liver Diseases
City
Miami
State/Province
Florida
Country
United States
City
Sarasota
State/Province
Florida
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Digestive and Liver Disease Clinic
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Virology Treatment Center, Maine Medical Center
City
Portland
State/Province
Maine
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
St Louis University
City
St Louis
State/Province
Missouri
Country
United States
Facility Name
The Nebraska Medical Center
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Columbia Gastroenterology Associates, PA
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
Country
United States
City
Annandale
State/Province
Virginia
Country
United States
Facility Name
University of Virginia Health Systems
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
Country
United States
City
Vienna
Country
Austria
Facility Name
University of Calgary Medical Clinic
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University of British Columbia Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hospital Henri Mondor
City
Creteil
Country
France
City
Lyon
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Pessac
Country
France
City
Vandoeuvre
Country
France
City
Berlin
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
University of Cologne
City
Cologne
Country
Germany
Facility Name
Uniklinik Duesseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
City
Frankfurt
Country
Germany
City
Hannover
Country
Germany
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Facility Name
Erasmus MC Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Fundacion de Investigation de Diego
City
Santurce
Country
Puerto Rico
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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