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Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Hereditary Hemochromatosis (HH) Patients

NCT ID: NCT01398644

Last Updated: 2013-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-12-31

Brief Summary

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Hereditary hemochromatosis (HH) is a genetic disorder of iron metabolism, resulting in excessive iron overload. Phlebotomy is currently the standard therapy. More recently Therapeutic Erythrocytapheresis (TE) has become a new therapeutic modality, which potentially offers a more efficient method to remove iron overload with fewer procedures.In the proposed clinical trial the investigators will examine whether TE can keep the ferritin levels in patients requiring maintenance therapy below 50 microg/L, with minimally half the number of treatment procedures when compared to current standard therapy by P.

Detailed Description

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The research population exists of patients with HH ( by genetic analysis confirmed as homozygous for C282Y) living in south-east of the Netherlands and currently treated with phlebotomy as maintenance treatment to keep their serum ferritin levels \< 50 ug/l. Ferritin level at start of the inclusion between 30-50ug/l. Exclusion criteria are: patient receiving other therapies such as chelating therapy or forced dietary regimen, further patients with excessive overweight (BMI\>35). After enrollment the patients will be randomized to start either with TE or continue with P. After a year of treatment and being at a serum ferritin level \<50ug/l, patients will continue the study but then being treated with the other of the two treatments. Randomization will be done by blocked randomization.

Conditions

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Hereditary Hemochromatosis

Keywords

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Phlebotomy Therapeutic erythrocytapheresis Hereditary Hemochromatosis maintenance therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Phlebotomy -intervention phlebotomy

Patients are treated with phlebotomy if ferritin level \>50 ug/l

Group Type ACTIVE_COMPARATOR

Phlebotomy and erythrocytapheresis

Intervention Type OTHER

Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

Erythrocytapheresis

Patients are treated with erythrocytapheresis if serum ferritin level \>50ug/l

Group Type EXPERIMENTAL

Phlebotomy and erythrocytapheresis

Intervention Type OTHER

Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

Interventions

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Phlebotomy and erythrocytapheresis

Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* homozygous for C282Y
* currently treated with phlebotomy as maintenance therapy for at least 6 month
* ferritin level between 30-50 micog/L
* age 18 years an older
* weight more than 50 kg
* signed informed consent
* willingness to fill out additional questionnaires at three points in time

Exclusion Criteria

* chelating therapy
* forced dietary regime
* aged below 18 years
* excessive overweight ( BMI more than 35)
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Atrium Medical Center

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Orbis Medical Centre

OTHER

Sponsor Role collaborator

Sanquin Research & Blood Bank Divisions

OTHER

Sponsor Role lead

Responsible Party

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Eva Rombout

Transfusion specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Rombout, MD

Role: PRINCIPAL_INVESTIGATOR

Sanquin Blood Supply

Locations

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University Hospital Maastricht

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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07-2-104

Identifier Type: -

Identifier Source: org_study_id