Chonic hepatitis C
Conditions
Interventions
Trade Name: Copegus
Pharmaceutical Form: Tablet
INN or Proposed INN: ribavirin
CAS Number: 66510-90-5
Current Sponsor code: virid
Other descriptive name: ribavirin
Concentration unit: mg milligram(s)
Sponsors
Foundation for Liver Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Hepatitis C genotype 1 or 4 • High viral load (>400,000 IU/ml) • Indication for antiviral treatment or patient’s desire for antiviral treatment • Hepatitis C treatment naïve • Liver biopsy within 3 years of the date of the screening visit or when liver biopsy is contraindicated e.g. in patients with clotting diseases e.g hemophilia and von Willebrand disease or when a patient refuses to undergo a new liver biopsy in case the liver biopsy is older than 3 years, substitution by fibroscan is allowed. • Age 18-70 years 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: • Signs of progressive liver disease, beyond generally accepted criteria for HCV antiviral therapy: ? serum bilirubin >35 µmol/l, or albumin 4 sec prolonged or platelets 500.000/mm³ • History or evidence of risk of thrombosis • Poorly controlled hypertension • Other acquired or inherited causes of liver disease that could explain liver disease activity (if an indicator is present at screening, additional examinations should be done to confirm or rule out the diagnoses): ? Alcoholic liver disease (indicator: MCV>100) ? Obesity induced liver disease (indicators: steatosis proven by biopsy or ultrasound in association with a body mass index >30) ? Drug related liver disease (indicator: positive history of hepatic toxic drug intake with a causal relation) ? Auto-immune hepatitis (indicators: IgG >30g/l, anti smooth-muscle or antinuclear antibodies titer ?1:40) ? Hemochromatosis (indicator: ferritin >1000 µg/l) ? Wilson’s disease (indicator: ceruloplasmin (28 drinks/week). If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · HCV-RNA negativity by qualitative assay 24 weeks after end of treatment (sustained virological response, SVR);Secondary Objective: · HCV-RNA negativity at week 4 (rapid virologic response, RVR) · HCV-RNA negativity at week 12 (complete early virologic response, cEVR) · HCV-RNA = 2log10 drop at week 12, but HCV-RNA still detectable (partial early virologic response, pEVR) · HCV-RNA negativity at week 48 (end of treatment response, ETR) · Relapse rate after end of treatment response · Safety (serious adverse events, grade 4 NCI toxicity) · Tolerability of peginterferon alfa-2a and high-dose ribavirin (percentage of patients completing treatment on full or >80% of total intended dose and reasons for dose adjustments) · Normalization of serum ALT at the end of therapy and and at the end of follow-up · Health related quality of life assessment using SF-36 questionnaires ;Primary end point(s): · HCV-RNA negativity by qualitative assay 24 weeks after end of treatment (sustained virological response, SVR) | — |
Countries
Netherlands
Outcome results
None listed