Clinical trial NCT00336479: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2006-06-13
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
timeFrame: 24 weeks after the completion of study drug dosing (up to Week 72)
Secondary outcomes:
measure: Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
timeFrame: 12 weeks after the completion of study drug dosing (up to Week 60)
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 48
measure: Number of Subjects With Viral Relapse
timeFrame: After last dose of study drug up to antiviral follow-up (up to Week 72)
measure: Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
timeFrame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Call For Information
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Palo Alto
country: United States
facility: Stanford University Liver Research
state: California
city: San Francisco
country: United States
facility: Call For Information
state: California
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Gainesville
country: United States
facility: Shands Hospital University of Florida
state: Florida
city: Miami
country: United States
facility: Call for Information
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Clarian Hospital
state: Indiana
city: Baton Rouge
country: United States
facility: Gulf Coast Research Associates
state: Louisiana
city: Baltimore
country: United States
facility: Call For Information
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Call for Information
state: Massachusetts
city: Worcester
country: United States
facility: Call For Information
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Call For Information
state: Minnesota
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Manhasset
country: United States
facility: Call For Information
state: New York
city: New York
country: United States
facility: Call for Information
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Call For Information
state: North Carolina
city: Durham
country: United States
facility: Call For Information
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase/ Temple Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Dallas
country: United States
facility: Methodist Hospital of Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Annandale
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Charlotteville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Santurce
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.