Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C (MEN_EPID)
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|ClinicalTrials.gov Identifier: NCT01402583|
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : October 21, 2011
Menopause represents a critical period in a woman's life as the hormonal changes and the failing ovarian function not only determine relevant modifications in the reproductive function but also in many other conditions and organs that apparently are scarcely linked with hormones. The PI's centre has among its main goals the treatment of chronic liver disease; in the last years, a increasing interest in gender-related issues has grown.
Goal of this study is to verify the impact of menopause on response to antiviral therapy for CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic, clinical and biochemical data as well data regarding the reproductive history, time, type, length of estrogen deprivation and of hormone-replacement therapy will be collected.
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis C||Drug: PEG IFN/Ribavirin|
The study is designed retrospective epidemiological cohort study. Overall, a group of 442 women (168 still in fertile age; 274 menopausal) with HCV-positive CAH who underwent PEG IFN treatment in the last 5 years will be evaluated. For comparison, a group of 548 HCV-positive males with CAH will be evaluated. Liver biopsies before undergoing standard antiviral therapy will be scored for fibrosis, inflammation and steatosis. In women the presence, type and timing of menopause, associated hormonal/metabolic features and serum interleukin-6 (IL-6) and hepatic tumor necrosis factor-α (TNF-α) levels will be evaluated.
The primary endpoint will be evaluation of SVR in females (in fertile and menopausal age) and in males.
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C - An Epidemiological Study|
|Study Start Date :||July 2011|
|Primary Completion Date :||August 2011|
|Study Completion Date :||September 2011|
Subjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment
Drug: PEG IFN/Ribavirin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402583
|Modena, Italy, 41124|
|Principal Investigator:||ERICA VILLA, Prof||University of Modena & Reggio Emilia|