Hereditary HemochromatosisPhase 2/3NCT00440986
Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
A Phase 2/3 study testing Eritrocytoapheresis in people with Hereditary Hemochromatosis, run by San Filippo Neri General Hospital at 1 site in Italy.
Trial summary
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Hemochromatosis
- What is being tested?
- Eritrocytoapheresis
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2003to Dec 2006
- Phase
- Phase 2/3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patiens newly diagnosed having Hereditary Hemochromatosis
Who cannot join
- Age < 18 yrs.
- Not obese (BMI <30)
- Not consuming alchol beverages,
- Not affected by systemic diseases and known hepatic viruses
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Transfusion Medicine-San Filippo Neri General Hospital
Rome, 00135
About this study
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH
Read the detailed description
Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis
- Conditions
- Hereditary Hemochromatosis
- Being tested
- Eritrocytoapheresis
- Keywords
- Clinical Management, Phlebotomy, Eritrocytoapheresis
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EritrocytoapheresisProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To prospectively determine the best choice of tretment in HH
To evaluate the global outcome according to treatment choice
Secondary outcomes (1)
To evaluate the outcome of specific clinical features according to treatment choice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startApr 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hereditary HemochromatosisStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- San Filippo Neri General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Francesco Equitani, M.D., Principal investigator, San Filippo Neri General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440986
- Sponsor's protocol ID
- CMHHPE
- Other IDs
- HH1
- Status last verified
- Feb 2007
- First submitted
- 26 Feb 2007
- Last updated
- 1 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. doi: 10.1056/NEJMra031573. No abstract available.
PubMed 15175440Equitani F, Fernandez-Real JM, Menichella G, Koch M, Calvani M, Nobili V, Mingrone G, Manco M. Bloodletting ameliorates insulin sensitivity and secretion in parallel to reducing liver iron in carriers of HFE gene mutations. Diabetes Care. 2008 Jan;31(1):3-8. doi: 10.2337/dc07-0939. Epub 2007 Oct 24.
PubMed 17959863
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis
- ClinicalTrials.gov ID
- NCT00440986
- Acronym / sponsor ID
- CMHHPE
- Conditions
- Hereditary Hemochromatosis
- Keywords
- Clinical Management, Phlebotomy, Eritrocytoapheresis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- San Filippo Neri General HospitalUniversity, hospital or other
- Study start
- Apr 2003
- Study completion
- Dec 2006
- First posted
- 27 Feb 2007 (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.
The purpose of study is to determine the best and durable choice of treatment between phlebotomy and eritrocytoapheresis in the medium- and long-term clinical management of HH
Detailed description
Patients affected by Hereditary hemochromatosis need a completeinitial staging of disease, a correct clinical management, a good chance of treatment and long-term follow-up. Clinical manifestations at presentation and during follow-up may consistently vary according to diagnostic criteria, treatment options and follow-up durability, up to the interruption. So, 25 caucasian patients, 16 males and 6 females of age >18 yrs. have been consecutively diagnosed and randomly included into two arms of treatment, phlebotomy vs. eritrocytoapheresis, evaluating, at baseline and 6-12-18-24-36 months, the clinical status concerning liver, kidney, pancreas, heart, endocrine iron overload and function and final outcome related to therapeutic strategy, including the cost/effectiveness analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patiens newly diagnosed having Hereditary Hemochromatosis
Key exclusion criteria (4 listed)
- Age < 18 yrs.
- Not obese (BMI <30)
- Not consuming alchol beverages,
- Not affected by systemic diseases and known hepatic viruses
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 |
|---|---|---|
| Eritrocytoapheresis | Procedure or surgery | – |
Primary outcome
To prospectively determine the best choice of tretment in HH
To evaluate the global outcome according to treatment choice
1 secondary outcome
To evaluate the outcome of specific clinical features according to treatment choice
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 1 Mar 2007.
- Background: PubMed 15175440Pietrangelo A. Hereditary hemochromatosis--a new look at an old disease. N Engl J Med. 2004 Jun 3;350(23):2383-97. doi: 10.1056/NEJMra031573. No abstract available.
- Derived from this study: PubMed 17959863Equitani F, Fernandez-Real JM, Menichella G, Koch M, Calvani M, Nobili V, Mingrone G, Manco M. Bloodletting ameliorates insulin sensitivity and secretion in parallel to reducing liver iron in carriers of HFE gene mutations. Diabetes Care. 2008 Jan;31(1):3-8. doi: 10.2337/dc07-0939. Epub 2007 Oct 24.
Related trials for Hereditary Hemochromatosis
Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Active, not recruiting
Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis
Haemochromatosis
RecruitingPhase 1/2
A Study to Evaluate BBI-001 in Healthy Volunteers and in Patients With Hereditary Hemochromatosis
Hereditary Hemochromatosis
RecruitingObservational study
An Observational Study Evaluating Patients With Chronic Liver Diseases Associated With Hepatic Steatosis
Chronic Liver Disease
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.
Francesco Equitani, M.D. principal investigator
San Filippo Neri General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eritrocytoapheresis in people with Hereditary Hemochromatosis, run by San Filippo Neri General Hospital 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 1 inclusion and 4 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 1 Mar 2007. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
To prospectively determine the best choice of tretment in HH. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00440986, which also lists 2 linked publications.
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 1 Mar 2007.