Chronic hepatitis C virus infection
Conditions
Interventions
Trade Name: Pegasys
Product Name: Pegasys
Pharmaceutical Form: Injection*
Trade Name: Copegus
Pharmaceutical Form: Tablet
Sponsors
Májbetegekért Alapítvány
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male and female patients above 18 and below 65 years of age chronically infected with genotype 1 HCV receiving combined Pegasys&Copegus treatment first time in-line with the valid treatment guideline approved by the National Interferon Committee (see attached guideline) • Subgroup 1: - Positive HCV PCR result at week 12 of the ongoing treatment - ALT > 1ULN, but the value decreased by week 12 • Subgroup 2: - ALT was normal and PCR was positive at week 12, therefore combined treatment could be continued between week 12 and 24 based on the approved guideline - Positive HCV RNA PCR at week 24 of the ongoing treatment - GPT =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • • Women with ongoing pregnancy or breast feeding • Therapy with any systemic anti-neoplastic or immunomodulatory treatment at inclusion or within 6 months prior to it • Any investigational drug usage at inclusion or within 6 weeks prior to it • Co/infection with hepatitis A, B or HIV • Any chronic liver disease other than HCV infection • Sign or symptom of hepatocellular carcinoma • Decompensated liver disease • History of depression or any other relevant psychiatric disease which, in the opinion of a psychiatrist or neurologist, contraindicates study therapy • Uncontrolled thyroid dysfunction • Severe retinopathy • Evidence of regular alcohol consumption at inclusion or within 1 year prior to it • Any side effect probably caused by ongoing combined treatment which, in the opinion of the investigator, contraindicates continuation of the therapy or necessitates dose reduction of any drug in the combination therapy • Unwillingness to provide informed consent • Subgroup 1: Laboratory findings at week 16 of the ongoing combined Pegasys&Copegus treatment: - ANC 1,5 ULN • Subgroup 2: Laboratory findings at week 28 of the ongoing combined Pegasys&Copegus treatment: - ANC 1,5 ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment;Main Objective: Sustained viral response given to continuation or prolongation of combined Pegasys&Copegus treatment;Secondary Objective: Histological response given to continuation or prolongation of combined Pegasys&Copegus treatment measured by non-invasive methods | — |
Countries
Hungary
Outcome results
None listed