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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 Center Boston, Massachusetts  02215
Cedars-Sinai Medical Center Los Angeles, California  90048
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75235-8897
Baylor University Medical Center Dallas, Texas  75246
Froedtert Memorial Lutheran Hospital Milwaukee, Wisconsin  53226
Saint Louis University St. Louis, Missouri  63104
Henry Ford Health System Detroit, Michigan  48202
University of Chicago Medical Center Chicago, Illinois  60637
University of Colorado Hospital Denver, Colorado  80262
University of Cincinnati College of Medicine Cincinnati, Ohio  
Metropolitan Research Fairfax, Virginia  
University of Pennsylvania Hospital Philadelphia, Pennsylvania  
University of New Mexico Albuquerque, New Mexico  87131
McGuire VA Medical Center Richmond, Virginia  23249
Columbia University Medical Center New York, New York  10032
University of Virginia Health System Charlottesville, Virginia  22903
Call For Information Phoenix, Arizona  
Stanford University Liver Research Palo Alto, California  
Call For Information San Francisco, California  
South Denver Gastroenterology Englewood, Colorado  
Shands Hospital University of Florida Gainesville, Florida  32610
Call for Information Miami, Florida  
Clarian Hospital Indianapolis, Indiana  46202
Gulf Coast Research Associates Baton Rouge, Louisiana  
Call For Information Baltimore, Maryland  
Call for Information Boston, Massachusetts  
Call For Information Rochester, Minnesota  
Call For Information Manhasset, New York  
Call For Information Chapel Hill, North Carolina  
Fox Chase/ Temple Cancer Center Philadelphia, Pennsylvania  19140
Methodist Hospital of Dallas Dallas, Texas  
Alamo Medical Research San Antonio, Texas  78215