Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Th... | NCT00202436

Studies
Haemochromatosis:Phlebotomy Versus Erythrocytapheresis Therapy

NCT00202436

Sponsor

Sanquin Research & Blood Bank Divisions

Status

Completed

Last Update Posted

Oct 20, 2009Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Hemochromatosis

Interventions

Phlebotomy
Erythrocytapheresis

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Dec 2008Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2009

Last Update Posted Date

Oct 20, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sanquin Research & Blood Bank DivisionsOTHER

Collaborators

Name	Class
Maastricht University Medical Center	OTHER
Atrium Medical Center	OTHER
Radboud University Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Phlebotomy	Procedure: Phlebotomy Procedure: Erythrocytapheresis
2	Active Comparator	Erythrocytapheresis	Procedure: Phlebotomy Procedure: Erythrocytapheresis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phlebotomy	Procedure	Removal of 500 ml whole blood	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment duration and number of treatments		Ferritine value 50 microgr/l

Secondary Outcomes

Measure	Description	Time Frame
Decline in hemoglobin levels, restitution in liver functions, patient discomfort en costs		Ferritine value 50microgr/l

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hereditary haemochromatosis patients

Exclusion Criteria:

Malignancies, severe arrhythmias, congestive heart failure and/or recent angina, severe liver disease, epileptic seizures preceding in last 3 months before planned treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Rombout, MD	Sanquin Research and Blood Bank Divisions	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanquin Blood Bank Southeast Region		Maastricht		6229 GR	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33368569	Derived	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.
21848963

ID	Term
D008664	Metal Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

ID	Term
D018962	Phlebotomy
D001815	Bloodletting

ID	Term
D001800	Blood Specimen Collection
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures