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

Hereditary Hemochromatosis Clinical Trial

Official title:

Erythrocytapheresis Versus Phlebotomy as Maintenance Therapy in Patients With Hereditary Hemochromatosis; a Randomised, Single Blinded Sequential, Cross-over Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01398644
• Other study ID #: 07-2-104
• Status: Unknown status
• Phase: Phase 3
• First received: July 19, 2011
• Last updated: December 3, 2013
• Start date: May 2008
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Sanquin Research & Blood Bank Divisions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemochromatosis
• Hereditary Hemochromatosis

Intervention

Other:
• Phlebotomy and erythrocytapheresis
Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (5)

Lead Sponsor	Collaborator
Sanquin Research & Blood Bank Divisions	Atrium Medical Center, Maastricht University Medical Center, Orbis Medical Centre, Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in number of required treatments and the interval between treatments per year to keep the serum ferritin levels between 30-50 microg/L		one year after first phlebotomy treatment and one year after first erythrocytapheresis treatment