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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 to 12 months after starting phlebotomy therapy

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 to 12 months after starting phlebotomy therapy

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MCV drops 1-3% below baseline

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

~1220

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health Clinical Center (CC)Lead Sponsor

383 Previous Clinical Trials

880,388 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently being signed up for this research project?

"That is correct, this clinical trial has an open call for participants and the listing can be found on clinicaltrials.gov. This specific study was first posted on 1/1/2001 with a most recent edit made on 10/26/2022. They are seeking 1000 individuals to take part in this research project at 2 locations."

Answered by AI

What is the sample size of this experiment?

"That is correct. The clinicaltrials.gov website indicates that the trial is still recruiting patients. This research was first made public on January 1st, 2001 and the latest update was on October 26th, 2022. They are hoping to enroll 1000 individuals at 2 sites."

Answered by AI

Has this therapeutic method been federally cleared?

"This treatment's safety has been supported by some data in Phase 2 trials, meaning there is not yet clinical evidence of its efficacy. Our team rates it a 2 on the Power scale."

Answered by AI