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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00336479
First received: June 9, 2006
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis C
Drug: Telaprevir
Drug: Ribavirin
Drug: Pegylated Interferon Alfa 2a
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

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 [ Time Frame: 24 weeks after the completion of study drug dosing (up to Week 72) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks after the completion of study drug dosing (up to Week 60) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After last dose of study drug up to antiviral follow-up (up to Week 72) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 ] [ Designated as safety issue: No ]
    Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.


Enrollment: 263
Study Start Date: June 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
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.
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Other: Placebo
matching placebo tablet
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
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.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Experimental: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
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.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a
Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
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.
Drug: Telaprevir
tablet
Other Name: VX-950
Drug: Ribavirin
tablet
Other Name: RBV
Drug: Pegylated Interferon Alfa 2a
Solution for injection
Other Name: Peg-IFN-alfa-2a

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  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: NCT00336479

  Hide Study Locations
Locations
United States, Arizona
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Phoenix, Arizona, United States
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Liver Research
Palo Alto, California, United States
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San Francisco, California, United States
United States, Colorado
University of Colorado Hospital
Denver, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
United States, Florida
Shands Hospital University of Florida
Gainesville, Florida, United States, 32610
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Miami, Florida, United States
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States
United States, Indiana
Clarian Hospital
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Gulf Coast Research Associates
Baton Rouge, Louisiana, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States
United States, Minnesota
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Rochester, Minnesota, United States
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, New York
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Manhasset, New York, United States
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New York, New York, United States
Columbia University Medical Center
New York, New York, United States
United States, North Carolina
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Fox Chase/ Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Methodist Hospital of Dallas
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States, 78215
United States, Virginia
Inova Fairfax Hospital
Annandale, Virginia, United States, 22003
University of Virginia Health System
Charlotteville, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States, 22031
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States
Puerto Rico
Fundacion de Investigacion de Diego
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
  More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT00336479     History of Changes
Other Study ID Numbers: VX05-950-104
Study First Received: June 9, 2006
Results First Received: June 22, 2011
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014