VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

Completed · Phase 3

Conditions studied: Genotype 1 Chronic Hepatitis C, Treatment Naive

In brief

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

Key facts

Study ID

NCT01241760

Run by

Janssen Infectious Diseases BVBA

People needed

744

Starts

2010-12-01

Expected to finish

2012-11-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
• Patients should not have had any previous treatment for hepatitis C
• Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
• Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
• A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

You may not qualify if…

• Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
• Patient has a pre-existing psychiatric condition
• Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
• Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
• Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Aurora, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Bradenton, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Downers Grove, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Lutherville, Maryland, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Egg Harbor Twp, New Jersey, United States
• Study site — Santa Fe, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Statesville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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