Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT00336479
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 263
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir 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. PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Ribavirin 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. Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Ribavirin 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 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. PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Pegylated Interferon Alfa 2a 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Pegylated Interferon Alfa 2a 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. PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week Placebo 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Pegylated Interferon Alfa 2a 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. Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Pegylated Interferon Alfa 2a 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Ribavirin 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. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Ribavirin 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.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing 24 weeks after the completion of study drug dosing (up to Week 72) 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
Name Time Method Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing 12 weeks after the completion of study drug dosing (up to Week 60) 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) Baseline up to Week 48 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 After last dose of study drug up to antiviral follow-up (up to Week 72) 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 Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Trial Locations
- Locations (28)
Fox Chase/ Temple Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
Call for Information
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Inova Fairfax Hospital
🇺🇸Annandale, Virginia, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Methodist Hospital of Dallas
🇺🇸Dallas, Texas, United States
Stanford University Liver Research
🇺🇸Palo Alto, California, United States
Gulf Coast Research Associates
🇺🇸Baton Rouge, Louisiana, United States
University of Virginia Health System
🇺🇸Charlotteville, Virginia, United States
University of Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Call For Information
🇺🇸Durham, North Carolina, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Colorado Hospital
🇺🇸Denver, Colorado, United States
Clarian Hospital
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Cincinnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Froedtert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
Shands Hospital University of Florida
🇺🇸Gainesville, Florida, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States