Terapia PEG-Interferone alfa 2B+Ribavirina versus terapia PEG-Interferone alfa 2B + Ribavirina+ Terapia ormonale sostitutiva (TOS) nella prevenzione della progressione della fibrosi epatica nell’epatite cronica HCV positiva in eta' post-menopausale - ND
- Conditions
- Women in post-menopause with Chronic HCV positive hepatitisMedDRA version: 9.1Level: SOCClassification code 10019805Term: Hepatobiliary disorders
- Registration Number
- EUCTR2008-001260-36-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA POLICLINICO DI MODENA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
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
Age > 70
Suspected hypersensitivity to Interferon, PEG-Interferon or Ribavirin
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method