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NCT00007150 · ClinicalTrials.gov registry record · Phase 2
Treatment of Hemochromatosis
A Phase 2 study of Hemochromatosis, sponsored by National Institutes of Health Clinical Center (CC).
- Active
- Registry status
- Phase 2
- Development phase
- 622
- Enrollment target
- 1
- Study location
NCT00007150 is a Phase 2 study of Hemochromatosis that is active but no longer recruiting, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 622 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00007150, a Phase 2 study of Hemochromatosis, is active but no longer recruiting, sponsored by National Institutes of Health Clinical Center (CC).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 622 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the effectiveness of a test called MCV in guiding phlebotomy (blood drawing) therapy in patients with hemochromatosis an inherited disorder that causes too much iron to be absorbed by the intestine. The excess damages body tissues, most severely in the liver, heart, pancreas and joints. Because iron is carried in the hemoglobin of red blood cells, removing blood can effectively lower the body s iron stores. Patients with hemochromatosis undergo weekly phlebotomy treatments (1 pint per session) to deplete iron stores. This usually requires 10 to 50 treatments, after which blood is drawn every 8 to 12 weeks to prevent a re-build up of iron. A test that measures ferritin a protein involved in storing iron is commonly used to guide phlebotomy therapy in hemochromatosis patients. This study will compare the usefulness of the ferritin test with that of MCV, which measures red blood cell size, in guiding phlebotomy therapy. In addition, the study will 1) examine whether keeping iron levels low during maintenance therapy can help heal severe liver disease and improve arthritis in affected patients, and 2) design a system for making blood collected from hemochromatosis donors available for transfusion into other patients. Patients 15 years and older with diagnosed hemochromatosis or very high iron levels suggesting possible hemochromatosis may be eligible for this study. Candidates will have a history, physical evaluation, review of medical records and blood tests, and complete a symptoms questionnaire. Participants will have the following procedures: * Phlebotomy therapy every 1 to 2 weeks, depending on iron levels * Blood sample collection for blood cell counts and iron studies at every phlebotomy session * Blood sample collection (about 2 tablespoons) every 1 to 2 weeks after iron stores have been depleted * Phlebotomy every 8 to 12 weeks after iron stores are used up to prevent re-build up of excess iron With each blood donation that will be
Conditions Studied
Interventions
- PROCEDURE Phlebotomy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 622 participants |
| Start Date | 2001-01-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00007150
The ClinicalTrials.gov registry entry for NCT00007150 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 622 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hemochromatosis appearing as the primary indexed condition, and to 1 intervention - of which Phlebotomy is the first listed.
NCT00007150 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00007150 about?
NCT00007150 is a clinical study titled "Treatment of Hemochromatosis". This study will evaluate the effectiveness of a test called MCV in guiding phlebotomy (blood drawing) therapy in patients with hemochromatosis an inherited disorder that causes too much iron to be absorbed by the intestine. The excess damages body tissues, most severely in the liver, heart, pancreas...
What is the current status of trial NCT00007150?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 622 participants. The study started on 2001-01-01. Estimated completion is 2026-12-31.
What conditions does trial NCT00007150 study?
This clinical trial studies the following conditions: Hemochromatosis.
What interventions are being tested in trial NCT00007150?
The interventions under investigation include: Phlebotomy (PROCEDURE).
Who is sponsoring clinical trial NCT00007150?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007150 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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