Women in post-menopause with Chronic HCV positive hepatitis MedDRA version: 9.1 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders
Conditions
Interventions
Product Name: Peginterferon alfa-2b
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Peginterferon alfa-2b
Concentration type: equal
Product Name: Ribavirin
Pharmaceutical Form: Capsu
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women age from menopause to 70 years old Chronic HCV positive hepatitis 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: Age > 70 Suspected hypersensitivity to Interferon, PEG-Interferon or Ribavirin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction of fibrosis progression and liver cirrhosis in post-menopausal women with chronic HCV positive hepatitis;Secondary Objective: Efficacy of hormone replacement therapy + Interferon + Peg-Interferon + Rivabirin in post-menopausal women compared to pre-menopausal women;Primary end point(s): Reduction of fibrosis progression and liver cirrhosis in post-menopausal women with chronic HCV positive hepatitis | — |
Countries
Italy
Outcome results
None listed