PER-067-01
Completed
N/A
MULTICENTER PROGRAM EXTENDED OPEN MODALITY OF ACCESS WITH ALPHA 2A (RO 25-8310) AS A MONOTERAPY AND COMBINATION THERAPY WITH RIVABIRIN (RO 20-9963) IN PATIENTS WITH CHRONIC HEPATITIS C
PRODUCTOS ROCHE Q.F.S.A.,0 sites0 target enrollmentOctober 19, 2001
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- -B171 Acute hepatitis C
- Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male patients and women\> 18 years of age
- •Serological evidence of chronic hepatitis C infection, using a test to detect anti\-HCV antibodies
- •HCV RNA detectable in the serum
- •Elevated ALT serum activity
- •Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliac patients, in whom the biopsy is medically contraindicated, do not require such a procedure)
- •Compensated liver disease (Grade A according to the Child\-Pugh clinical classification)
- •Negative test for pregnancy in the urine or blood (for women with fertile potential), documented during the 24\-hour period before receiving the first dose of the study drug
- •All fertile men and women receiving ribavirin should use two forms of effective contraception during treatment and for 6 months after the end of treatment
Exclusion Criteria
- •Pregnant or nursing women
- •Systemic therapy with an antineoplastic or immunomodulatory treatment (including supraphysiological doses of steroids and radiation) \<6 months before the first dose of the study drug is administered
- •Administration of any investigational drug \<6 weeks before the first dose of the study drug
- •Active co\-infection with hepatitis A, hepatitis B and / or the human immunodeficiency virus (HIV)
- •History or other evidence of a medical condition associated with a chronic liver disease other than HCV (eg, hepatic metabolic disease, alcoholic liver disease, toxin exposures)
- •Signs or symptoms of hepatocellular carcinoma
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •Neutrophil count \<1500 cells / mm ^ or platelet count \<90000 cells / mm ^ in the selection
- •Serum creatinine level\> 1\.5 times the upper limit of normality in the selection
- •History of severe psychiatric illness, especially depression. Severe psychiatric illness is defined as treatment with an antidepressant medication or with a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time; or any history of the following: a suicide attempt, hospitalization because of a psychiatric illness, or a period of disability due to a psychiatric illness
Outcomes
Primary Outcomes
Not specified
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