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

Sponsor:

Collaborator:

Merck Sharp & Dohme Corp.

Information provided by (Responsible Party):

Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Chronic Hepatitis C	Drug: PEG IFN/Ribavirin

Detailed 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.

Study Design


Study Type :	Observational
Actual Enrollment :	1000 participants
Observational Model:	Cohort
Time Perspective:	Retrospective
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
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
PEG IFN/Ribavirin Subjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment	Drug: PEG IFN/Ribavirin PEG IFN/Ribavirin Other Names: Pegylated IFN 2a Pegasys Pegylated IFN 2b PegIntron Copegus Rebetol

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Italy
Gastroenterology Unit
Modena, Italy, 41124

Sponsors and Collaborators

Prof. Facchinetti Fabio

Merck Sharp & Dohme Corp.

Investigators


Principal Investigator:	ERICA VILLA, Prof	University of Modena & Reggio Emilia

More Information


Responsible Party:	Prof. Facchinetti Fabio, Prs admin, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier:	NCT01402583 History of Changes
Other Study ID Numbers:	RSO-321
First Posted:	July 26, 2011 Key Record Dates
Last Update Posted:	October 21, 2011
Last Verified:	October 2011

Keywords provided by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia:


Hepatitis C Gender Menopause Sustained viral response Cytokines

Additional relevant MeSH terms:


Hepatitis Hepatitis A Hepatitis C Hepatitis, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases	Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Ribavirin Antiviral Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents

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