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Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Telaprevir
Ribavirin
Pegylated Interferon Alfa 2a
Placebo
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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA Have been infected with hepatitis C virus for greater than (>) 6 months Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2 Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential) Female subjects must have a negative pregnancy test at all visits before the first dose Exclusion Criteria: Received any approved or investigational drug or drug regimen for the treatment of hepatitis C Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis Diagnosed or suspected hepatocellular carcinoma Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start Alcohol abuse or excessive use in the last 12 months Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)

Sites / Locations

  • Call For Information
  • Cedars-Sinai Medical Center
  • Stanford University Liver Research
  • Call For Information
  • University of Colorado Hospital
  • South Denver Gastroenterology
  • Shands Hospital University of Florida
  • Call for Information
  • University of Chicago Medical Center
  • Clarian Hospital
  • Gulf Coast Research Associates
  • Call For Information
  • Beth Israel Deaconess Medical Center
  • Call for Information
  • Call For Information
  • Henry Ford Health System
  • Call For Information
  • Saint Louis University
  • University of New Mexico
  • Call For Information
  • Call for Information
  • Columbia University Medical Center
  • Call For Information
  • Call For Information
  • University of Cincinnati College of Medicine
  • Fox Chase/ Temple Cancer Center
  • University of Pennsylvania Hospital
  • Baylor University Medical Center
  • Methodist Hospital of Dallas
  • University of Texas Southwestern Medical Center at Dallas
  • Alamo Medical Research
  • Inova Fairfax Hospital
  • University of Virginia Health System
  • Metropolitan Research
  • McGuire VA Medical Center
  • Froedtert Memorial Lutheran Hospital
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

Arm Description

Placebo (PBO) matched to telaprevir tablet orally 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 48 weeks.

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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.

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks.

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.

Outcomes

Primary Outcome Measures

Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
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).

Secondary Outcome Measures

Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
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.
Number of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. 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).
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.

Full Information

First Posted
June 9, 2006
Last Updated
June 25, 2014
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00336479
Brief Title
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
Official Title
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (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
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Arm Type
Placebo Comparator
Arm Description
Placebo (PBO) matched to telaprevir tablet orally 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 48 weeks.
Arm Title
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Arm Type
Experimental
Arm Description
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Arm Type
Experimental
Arm Description
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks.
Arm Title
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Arm Type
Experimental
Arm Description
Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
VX-950
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
RBV
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon Alfa 2a
Other Intervention Name(s)
Peg-IFN-alfa-2a
Intervention Description
Solution for injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
matching placebo tablet
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 Study Drug Dosing
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 study drug dosing (up to Week 72)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
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
12 weeks after the completion of study drug dosing (up to Week 60)
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 up to Week 48
Title
Number of Subjects With Viral Relapse
Description
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. 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
After last dose of study drug up to antiviral follow-up (up to Week 72)
Title
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Description
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Time Frame
Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA Have been infected with hepatitis C virus for greater than (>) 6 months Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2 Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential) Female subjects must have a negative pregnancy test at all visits before the first dose Exclusion Criteria: Received any approved or investigational drug or drug regimen for the treatment of hepatitis C Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis Diagnosed or suspected hepatocellular carcinoma Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start Alcohol abuse or excessive use in the last 12 months Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Call For Information
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Stanford University Liver Research
City
Palo Alto
State/Province
California
Country
United States
Facility Name
Call For Information
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
Shands Hospital University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Call for Information
City
Miami
State/Province
Florida
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Clarian Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Gulf Coast Research Associates
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Call For Information
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
Call for Information
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Call For Information
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Call For Information
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Call For Information
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Call for Information
City
New York
State/Province
New York
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
Country
United States
Facility Name
Call For Information
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Call For Information
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Cincinnati College of Medicine
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Fox Chase/ Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Methodist Hospital of Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Inova Fairfax Hospital
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
University of Virginia Health System
City
Charlotteville
State/Province
Virginia
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
Country
United States
Facility Name
Fundacion de Investigacion de Diego
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
19403902
Citation
McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104. Erratum In: N Engl J Med. 2009 Oct 8;361(15):1516.
Results Reference
derived

Learn more about this trial

Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

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