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Phlebotomy for Iron Overload

Phase 2
Waitlist Available
Led By Kamille A West-Mitchell, M.D.
Research Sponsored by National Institutes of Health Clinical Center (CC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elevated transferrin saturation and/or ferritin level without genotype findings listed above, but with elevated hepatic iron index on liver biopsy
Be older than 18 years old
Must not have
Age less than 15 years
Patients requiring therapeutic phlebotomy for reasons other than iron overload (polycythemia vera)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 12 months after starting phlebotomy therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness of two different tests in guiding phlebotomy therapy for patients with hemochromatosis, an inherited disorder that causes too much iron to be absorbed by the intestine.

Who is the study for?
This trial is for individuals aged 15 or older with diagnosed hemochromatosis, a condition where too much iron is absorbed by the body. It's also open to those with high iron levels suggesting hemochromatosis, and family members being screened for it. People can't join if they're under 15, need phlebotomy for other conditions like polycythemia vera, have certain illnesses that increase risk, are pregnant, or have iron overload not caused by hemochromatosis.
What is being tested?
The study tests whether MCV (a measure of red blood cell size) can guide phlebotomy therapy as effectively as the ferritin test in patients with hemochromatosis. Participants will undergo regular blood drawing sessions to manage their iron levels and may contribute blood for transfusions. Some may be evaluated further for liver disease or arthritis linked to their condition.
What are the potential side effects?
Phlebotomy side effects might include fatigue and dizziness due to sudden drops in iron levels after sessions. There's also a small risk of infection at the needle site. For those donating double red cells through apheresis, there could be additional discomfort from the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My iron levels are high, but I don't have the specific gene changes. A liver biopsy showed high iron.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am younger than 15 years old.
Select...
I need blood removal treatment for a condition other than too much iron.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 12 months after starting phlebotomy therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 12 months after starting phlebotomy therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MCV drops 1-3% below baseline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1/HH patientsExperimental Treatment1 Intervention
HH patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phlebotomy
2016
Completed Phase 3
~1200

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor
389 Previous Clinical Trials
30,879,122 Total Patients Enrolled
Kamille A West-Mitchell, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
3 Previous Clinical Trials
6,258 Total Patients Enrolled
Kamille A West, M.D.Principal InvestigatorNational Institutes of Health Clinical Center (CC)
3 Previous Clinical Trials
6,258 Total Patients Enrolled

Media Library

Phlebotomy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT00007150 — Phase 2
Iron Overload Research Study Groups: 1/HH patients
Iron Overload Clinical Trial 2023: Phlebotomy Highlights & Side Effects. Trial Name: NCT00007150 — Phase 2
Phlebotomy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00007150 — Phase 2
~25 spots leftby Dec 2025
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