Chronic hepatitis C
Conditions
Interventions
Trade Name: Copegus 200 mg
Product Name: Copegus
Product Code: R20-9963/J10
Pharmaceutical Form: Tablet
INN or Proposed INN: ribavirin
CAS Number: 36791-04-5
Concentration unit: mg milligram(s)
Con
Sponsors
Karolinska University Hospital, Huddinge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male and female patients =18 years of age •Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test •Genotype 1 •Non-response to a previous therapy with peginterferon alfa-2a/ribavirin combination therapy given for at least 12 weeks (defined as positive HCV-RNA test result at every assessment after initiation of PEG-IFN alfa-2a combination therapy, with at least one HCV-RNA test performed on treatment after at least 12 weeks therapy). •Detectable serum HCV-RNA •Elevated serum ALT levels •Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection (histological cirrhosis = fibrosis grade IV are excluded) •Compensated liver disease (Child-Pugh Grade A clinical classification) •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 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: •Women with ongoing pregnancy or breast feeding •Liver biopsy findings consistent with histological cirrhosis (fibrosis grade IV) or clinical evidence of cirrhosis •Therapy with any systemic anti-neoplastic or immune modulatory treatment •Any investigational drug (other than study drugs) =6 weeks prior to the first dose of study drug, •Co-infection with hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV) •Significant chronic liver disease other than HCV •Hepatocellular carcinoma •Decompensated liver disease •Neutrophil count 500 000/mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate therapeutic outcome in standard dosed Peginterferon alfa-2a combined with high dosed ribavirin in patients with CHC who were previously non-reponders to standard dosed combinationtherapy, and to evaluate the safety and tolerability of ribavirin given in an individual dose aiming at a plasma target concentration of > 15 mmol/L. ;Secondary Objective: To prospectively evaluate the validity of a revised pharmaokinetic formula for calculating the initial dose to achieve a targeted steady-state plasma concentration of ribavirin. ;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