Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

— MEN_EPID  

Official title:

Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C - An Epidemiological Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402583
• Other study ID #: RSO-321
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: October 20, 2011
• Start date: July 2011
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• All women treated for HCV chronic hepatitis, at the Unit Gastroenterology, University of Modena and Reggio Emilia, in the last 7 years.

• Control group is a cohort matched for age (ratio 1:1) selected from a group of 558 men with chronic HCV treated in the same period

Exclusion Criteria:

• No exclusion criteria aret pre-defined as the study includes all patients who were treated for chronic HCV hepatitis; exclusion was made upstream of the constitution of this cohort.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PEG IFN/Ribavirin
PEG IFN/Ribavirin

Locations

Country	Name	City	State
Italy	Gastroenterology Unit	Modena

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Facchinetti Fabio	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy,