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
- Conditions
- -B171 Acute hepatitis CAcute hepatitis CB171
- Registration Number
- PER-067-01
- Lead Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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
• History of a severe seizure disorder or habitual use of anticonvulsants
• History of any immunologically mediated disease, chronic lung disease associated with any functional limitation, severe heart disease, transplantation of major organs or other evidence of severe disease, malignancy or any other condition that could, in the opinion of the investigator, cause the patient not to be appropriate to be included in the study
• History of poorly controlled thyroid disease with prexrita medications, high concentrations of thyroid stimulating hormone (TSH), with elevation in antibodies against thyroid peroxidase and any clinical manifestation of thyroid disease
• Evidence of severe retinopathy (eg, cytomegalovirus retinitis (CMV, macular degeneration)
• Evidence of drug abuse (including excessive alcohol consumption) within one year of entering the study
• Inability or refusal to offer informed consent or not to accept the requirements of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:An Adverse Event is any unexpected medical occurrence in a patient or in a subject of a clinical investigation to which a pharmaceutical product was administered and which does not necessarily have any causal relationship with said treatment.<br>Measure:Frequency and profile of adverse events.<br>Timepoints:48 weeks<br>
- Secondary Outcome Measures
Name Time Method