Chronic Hepatitis CMEN_EPIDNCT01402583
Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C
An observational study of Chronic Hepatitis C, run by Prof. Facchinetti Fabio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- PEG IFN/Ribavirin
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C - An Epidemiological Study
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- PEG IFN/Ribavirin
- Keywords
- Hepatitis C, Gender, Menopause, Sustained viral response, Cytokines
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG IFN/RibavirinDrug
Also called Pegylated IFN 2a Pegasys, Pegylated IFN 2b PegIntron, Copegus, Rebetol
PEG IFN/Ribavirin
| Study group | Role | What they receive |
|---|---|---|
| PEG IFN/Ribavirin | Subjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment Receives: Drug: PEG IFN/Ribavirin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Facchinetti Fabio
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
- Investigators
- ERICA VILLA, Prof, Principal investigator, University of Modena & Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402583
- Sponsor's protocol ID
- RSO-321
- Acronym
- MEN_EPID
- Status last verified
- Oct 2011
- First submitted
- 25 Jul 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C - An Epidemiological Study
- ClinicalTrials.gov ID
- NCT01402583
- Acronym / sponsor ID
- MEN_EPID / RSO-321
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Gender, Menopause, Sustained viral response, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Prof. Facchinetti FabioUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG IFN/Ribavirin | – | Drug: PEG IFN/RibavirinSubjects with Hepatitis C undergoing PEG IFN/Ribavirin treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG IFN/RibavirinAlso: Pegylated IFN 2a Pegasys, Pegylated IFN 2b PegIntron, Copegus, RebetolPEG IFN/Ribavirin | Drug | PEG IFN/Ribavirin |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ERICA VILLA, Prof principal investigator
University of Modena & Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C, run by Prof. Facchinetti Fabio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2011.