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

NCT01398644 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Hereditary Hemochromatosis

Interventions

OTHER

Phlebotomy and erythrocytapheresis

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

Sponsors & Collaborators

  • Maastricht University Medical Center

    collaborator OTHER

  • Atrium Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Orbis Medical Centre

    collaborator OTHER

  • Sanquin Research & Blood Bank Divisions

    lead OTHER

Principal Investigators

  • Eva Rombout, MD · Sanquin Blood Supply

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01398644 on ClinicalTrials.gov