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

NCT01402583 | Completed

• 1 other identifier: RSO-321
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C; Gender; Menopause; Sustained viral response; Cytokines

Study Arms (1)

PEG IFN/Ribavirin

Subjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment

Drug: PEG IFN/Ribavirin

Interventions

PEG IFN/Ribavirin DRUG

PEG IFN/Ribavirin

Also known as: Pegylated IFN 2a Pegasys, Pegylated IFN 2b PegIntron, Copegus, Rebetol

PEG IFN/Ribavirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Prof. Facchinetti Fabio: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Gastroenterology Unit

Modena, 41124, Italy

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C; Coitus

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• ERICA VILLA, Prof

  University of Modena & Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prs admin

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 21, 2011

Record last verified: 2011-10

Locations

IT (1)