EUCTR2010-023669-23-CZActive, not recruitingNot Applicable
Multicenter, Open-Label, Early Access Program of Telaprevir in Combination With Peginterferon Alfa and Ribavirin in Genotype 1 Chronic Hepatitis C Subjects With Severe Fibrosis and Compensated Cirrhosis
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 3,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patient must have evidence of chronic Hepatitis C (genotype 1) infection.
- •2. Patient must have documentation of liver fibrosis assessed by liver biopsy or noninvasive test showing severe fibrosis or cirrhosis
- •3. Evidence of compensated liver disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
Exclusion Criteria
- •1. Patient is infected or co-infected with HCV of another genotype than genotype 1
- •2. Patient has signs or symptoms of HCC
- •3. Patient has a history of decompensated liver disease
- •4. Patient has a co-infection with active hepatitis B or HIV
Investigators
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