HemochromatosisPhase 3NCT00202436
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy
A Phase 3 study testing Phlebotomy and Erythrocytapheresis in people with Hemochromatosis, run by Sanquin Research & Blood Bank Divisions at 1 site in Netherlands.
Trial summary
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemochromatosis
- What is being tested?
- Phlebotomy and Erythrocytapheresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2004to Sep 2009
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hereditary haemochromatosis patients
Who cannot join
- Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
Read the detailed description
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
- Conditions
- Hemochromatosis
- Being tested
- Phlebotomy, Erythrocytapheresis
- Medical subject headings
- Hemochromatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlebotomyProcedure or surgery
Also called Bloodletting
Removal of 500 ml whole blood
ErythrocytapheresisProcedure or surgery
Also called Therapeutic erythrocytapheresis
machinal removal of erythrocytes
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Phlebotomy Receives: Procedure: Phlebotomy; Procedure: Erythrocytapheresis |
| 2 | Active comparator | Erythrocytapheresis Receives: Procedure: Phlebotomy; Procedure: Erythrocytapheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration and number of treatments
Measured: Ferritine value 50 microgr/l
Secondary outcomes (1)
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Measured: Ferritine value 50microgr/l
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2008
- Study completionSep 2009
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center
- Investigators
- Eva Rombout, MD, Principal investigator, Sanquin Research and Blood Bank Divisions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202436
- Sponsor's protocol ID
- PPO-C- 03-006
- Status last verified
- Oct 2009
- First submitted
- 13 Sep 2005
- Last updated
- 20 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rombout-Sestrienkova E, Winkens B, van Kraaij M, van Deursen CTBM, Janssen MCH, Rennings AMJ, Evers D, Kerkhoffs JL, Masclee A, Koek GH. A predictive model for estimating the number of erythrocytapheresis or phlebotomy treatments for patients with naive hereditary hemochromatosis. J Clin Apher. 2021 Jun;36(3):340-347. doi: 10.1002/jca.21867. Epub 2020 Dec 24.
PubMed 33368569Rombout-Sestrienkova E, Nieman FH, Essers BA, van Noord PA, Janssen MC, van Deursen CT, Bos LP, Rombout F, van den Braak R, de Leeuw PW, Koek GH. Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. Transfusion. 2012 Mar;52(3):470-7. doi: 10.1111/j.1537-2995.2011.03292.x. Epub 2011 Aug 16.
PubMed 21848963
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Erythrocytapheresis as Treatment for Hemochromatosis Patients.
- ClinicalTrials.gov ID
- NCT00202436
- Acronym / sponsor ID
- PPO-C- 03-006
- Conditions
- Hemochromatosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Atrium Medical Center, Radboud University Medical Center
- Study start
- Oct 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 Sep 2005 (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.
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. Results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
Detailed description
In this project we plan to evaluate the effectiveness of erythrocytapheresis against phlebotomy, both regarding the impact on the reduction in iron overload as well as reduction in patient "burden". Aspects of cost effectiveness will be included in the final analysis. The results of the study would allow decision-making based on Evidence Based Medicine on the "best" therapeutic options available for newly-diagnosed as well as existing primary hemochromatosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Phlebotomy, Procedure: ErythrocytapheresisPhlebotomy |
| 2 | Active comparator | Procedure: Phlebotomy, Procedure: ErythrocytapheresisErythrocytapheresis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hereditary haemochromatosis patients
Key exclusion criteria (1 listed)
- Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment
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 |
|---|---|---|
| PhlebotomyAlso: BloodlettingRemoval of 500 ml whole blood | Procedure or surgery | 1, 2 |
| ErythrocytapheresisAlso: Therapeutic erythrocytapheresismachinal removal of erythrocytes | Procedure or surgery | 1, 2 |
Primary outcome
Treatment duration and number of treatments
Time frame: Ferritine value 50 microgr/l
1 secondary outcome
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs
Time frame: Ferritine value 50microgr/l
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 20 Oct 2009.
- Derived from this study: PubMed 33368569Rombout-Sestrienkova E, Winkens B, van Kraaij M, van Deursen CTBM, Janssen MCH, Rennings AMJ, Evers D, Kerkhoffs JL, Masclee A, Koek GH. A predictive model for estimating the number of erythrocytapheresis or phlebotomy treatments for patients with naive hereditary hemochromatosis. J Clin Apher. 2021 Jun;36(3):340-347. doi: 10.1002/jca.21867. Epub 2020 Dec 24.
- Derived from this study: PubMed 21848963Rombout-Sestrienkova E, Nieman FH, Essers BA, van Noord PA, Janssen MC, van Deursen CT, Bos LP, Rombout F, van den Braak R, de Leeuw PW, Koek GH. Erythrocytapheresis versus phlebotomy in the initial treatment of HFE hemochromatosis patients: results from a randomized trial. Transfusion. 2012 Mar;52(3):470-7. doi: 10.1111/j.1537-2995.2011.03292.x. Epub 2011 Aug 16.
Related trials for Hemochromatosis
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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.
Eva Rombout, MD principal investigator
Sanquin Research and Blood Bank Divisions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phlebotomy and Erythrocytapheresis in people with Hemochromatosis, run by Sanquin Research & Blood Bank Divisions at 1 site in Netherlands.
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 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 20 Oct 2009. 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 Netherlands. 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 phase mean?
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?
Treatment duration and number of treatments (time frame: Ferritine value 50 microgr/l). 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 NCT00202436, 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 20 Oct 2009.