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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: Active Phase 2 study of Hemochromatosis, sponsored by National Institutes of Health Clinical Center (CC).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (368% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Response to phlebotomy therapy in HH patients, as evidenced by iron-depletion
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 |
What the registry record for NCT00007150 still lists
NCT00007150 is an interventional study that assigns participants to a tested intervention. The registered 622 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (368% higher).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00007150's enrollment target sits among peer trials
622 52nd of 2000 higher than 1,949 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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