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

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 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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Other: Placebo; Drug: Telaprevir

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: RBV; Drug: Pegylated Interferon Alfa 2a; Solution for injection; Other Names: 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: Ribavirin; tablet; Other Names: RBV; Drug: Pegylated Interferon Alfa 2a; Solution for injection; Other Names: Peg-IFN-alfa-2a; Drug: Telaprevir; tablet; Other Names: VX-950
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: Ribavirin; tablet; Other Names: RBV; Drug: Pegylated Interferon Alfa 2a; Solution for injection; Other Names: Peg-IFN-alfa-2a; Drug: Telaprevir; tablet; Other Names: VX-950
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: Ribavirin; tablet; Other Names: RBV; Drug: Pegylated Interferon Alfa 2a; Solution for injection; Other Names: Peg-IFN-alfa-2a; Drug: Telaprevir; tablet; Other Names: VX-950

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 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).	24 weeks after the completion of study drug dosing (up to Week 72)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks after the completion of study drug dosing (up to Week 60)
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 up to Week 48
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).	After last dose of study drug up to antiviral follow-up (up to Week 72)
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.	Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: June 9, 2006
• First Submitted That Met QC Criteria: June 9, 2006
• First Posted (Estimate): June 13, 2006

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: June 25, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• 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, Chronic; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; 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: VX05-950-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No