Description:

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; ODM derived from: https://clinicaltrials.gov/show/NCT01241760

Link:

https://clinicaltrials.gov/show/NCT01241760

Keywords:
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  1. 6/9/20
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

June 9, 2020

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License:
Creative Commons BY 4.0
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Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

Eligibility Genotype 1 Chronic Hepatitis C NCT01241760

Inclusion Criteria
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.
Exclusion Criteria
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).