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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Chronic Hepatitis C

Thank you

Trial Information

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


Inclusion Criteria:



- Hepatitis C virus Genotype 1 with detectable plasma HCV RNA

- Have been infected with Hepatitis C virus for >6 months.

- Seronegative for HbsAg and HIV1 and HIV2

- 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 Peg-IFN-a-2a or RBV 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
(NASH) 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).

Type of Study:

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

Outcome Measure:

Proportion of Subjects in Each Group With Undetectable Plasma HCV RNA, 24 Weeks After the Completion of the Assigned Study Drug Regimen

Outcome Time Frame:

24 weeks after the completion of study drug dosing

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Vertex Pharmaceuticals Incorporated

Authority:

United States: Food and Drug Administration

Study ID:

VX05-950-104

NCT ID:

NCT00336479

Start Date:

June 2006

Completion Date:

February 2008

Related Keywords:

  • Chronic Hepatitis C
  • Hepatitis
  • Hepatitis A
  • Hepatitis, Chronic
  • Hepatitis C
  • Hepatitis C, Chronic

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Cedars-Sinai Medical CenterLos Angeles, California  90048
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
Baylor University Medical CenterDallas, Texas  75246
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Saint Louis UniversitySt. Louis, Missouri  63104
Henry Ford Health SystemDetroit, Michigan  48202
University of Chicago Medical CenterChicago, Illinois  60637
University of Colorado HospitalDenver, Colorado  80262
University of Cincinnati College of MedicineCincinnati, Ohio  
Metropolitan ResearchFairfax, Virginia  
University of Pennsylvania HospitalPhiladelphia, Pennsylvania  
University of New MexicoAlbuquerque, New Mexico  87131
McGuire VA Medical CenterRichmond, Virginia  23249
Columbia University Medical CenterNew York, New York  10032
University of Virginia Health SystemCharlottesville, Virginia  22903
Call For InformationPhoenix, Arizona  
Stanford University Liver ResearchPalo Alto, California  
Call For InformationSan Francisco, California  
South Denver GastroenterologyEnglewood, Colorado  
Shands Hospital University of FloridaGainesville, Florida  32610
Call for InformationMiami, Florida  
Clarian HospitalIndianapolis, Indiana  46202
Gulf Coast Research AssociatesBaton Rouge, Louisiana  
Call For InformationBaltimore, Maryland  
Call for InformationBoston, Massachusetts  
Call For InformationRochester, Minnesota  
Call For InformationManhasset, New York  
Call For InformationChapel Hill, North Carolina  
Fox Chase/ Temple Cancer CenterPhiladelphia, Pennsylvania  19140
Methodist Hospital of DallasDallas, Texas  
Alamo Medical ResearchSan Antonio, Texas  78215