Chronic hepatitis C infection MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Trade Name: Pegasys 180 mcg / 135 mcg
Product Name: Pegasys
Pharmaceutical Form: Injection*
Trade Name: Copegus 200 mg / 400 mg
Product Name: Copegus
Pharmaceutical Form: Tablet
Sponsors
Karolinska University hospital Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • signed written informed consent • transplanted patients with histological proven hepatitis C relaps irrespective of response to a prior therapy before transplantation or whether untreated before transplantation • Male and female patients transplanted for end stage cirrhosis caused by hepatitis C virus with or without HCC >18 years of age with any genotype are eligible • A positive HCV RNA test in serum • Liver biopsy findings consistent with a histological relapse of hepatitis C on a protocol biopsy after liver transplantation with Fibrosis stage 1-3 • Compensated liver disease • Negative urine pregnancy test (for women of childbearing potential) • All fertile males and females must be using effective contraception during treatment and during the 6 months after treatment end • If possible immunosuppressive treatment should not include MMF or azathioprine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Liver biopsy findings consistent with firmly established cirrhosis (fibrosis grade IV) or clinical evidence of cirrhosis • Patients with signs of moderate – severe rejection (RAI score >=6) on the protocol biopsy which should be properly treated before the patients can be included • Any investigational drug (other than study drugs) 500 000/mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the number of patients achieving RVR, cRVR and SVR. - To evaluate compliance to PEG-INF, RBV and erytropoetin treatment;Secondary Objective: To study if and how the early HCV RNA kinetics (week 1, 2, 3, 4 and 8) and viral decline rate (second phase slope) can promote an early identification of patients with non-response who should discontinue treatment, as well as patients likely to relapse who may need prolonged treatment. ;Primary end point(s): Number of patients achieving sustained virological response defined as HCV-RNA negative 6 months after end of treatment | — |
Countries
Sweden
Outcome results
None listed