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

NCT ID: NCT01402583

Last Updated: 2011-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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PEG IFN/Ribavirin

Subjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment

PEG IFN/Ribavirin

Intervention Type DRUG

PEG IFN/Ribavirin

Interventions

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PEG IFN/Ribavirin

PEG IFN/Ribavirin

Intervention Type DRUG

Other Intervention Names

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Pegylated IFN 2a Pegasys Pegylated IFN 2b PegIntron Copegus Rebetol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Prof. Facchinetti Fabio

OTHER

Sponsor Role lead

Responsible Party

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Prof. Facchinetti Fabio

Prs admin

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ERICA VILLA, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Modena & Reggio Emilia

Locations

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Gastroenterology Unit

Modena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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RSO-321

Identifier Type: -

Identifier Source: org_study_id