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NCT00098280 · ClinicalTrials.gov registry record · Phase 3
Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria
A Phase 3 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
NCT00098280 is a Phase 3 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 75 participants.
The verdict
NCT00098280, a Phase 3 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
Study Summary
This study will examine the safety and effectiveness of the experimental drug eculizumab in treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder of red blood cells that leads to premature destruction of the cells and resulting anemia. Patients may be at high risk of blood clots and may develop bone marrow failure or aplastic anemia, with low white blood cell and platelet counts. Eculizumab is a monoclonal antibody that may help improve the survival of red blood cells. Patients 18 years of age and older with PNH who require blood transfusions for anemia and have received at least four transfusions in the 12 months preceding evaluation for this study may be eligible to enroll. Candidates are screened with a medical history, physical examination, and check of vital signs. Participants have an electrocardiogram (EKG) and blood and urine tests, and are vaccinated against Neisseria meningitides, a common bacteria that can cause a disabling or fatal type of meningitis. They then enter an observation phase of the study, with monthly visits during which they complete a questionnaire; update their health status, transfusion record, and medication use; have their vital signs checked and PNH symptoms evaluated; have blood and urine tests; and receive a transfusion, if necessary. These visits continue for up to 3 months until patients receive a "qualifying" transfusion; that is, a transfusion given as a consequence of a certain hemoglobin level with symptoms or a different level without symptoms. Patients are then randomly assigned to receive either eculizumab or a placebo (salt solution with no active ingredient). Both study medications are given intravenously (through a vein) over 30 minutes once a week for five doses and then once every 2 weeks for another 11 doses. At each treatment visit (study weeks 0-24), patients update their health status, transfusion records, and medication use; have their vital signs checked; and provide a blood sample.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-12 |
| Est. Completion | 2006-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098280
The ClinicalTrials.gov registry entry for NCT00098280 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT00098280 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00098280 about?
NCT00098280 is a clinical study titled "Eculizumab to Treat Paroxysmal Nocturnal Hemoglobinuria". This study will examine the safety and effectiveness of the experimental drug eculizumab in treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder of red blood cells that leads to premature destruction of the cells and resulting anemia. Patients may be at high risk of bloo...
What is the current status of trial NCT00098280?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2004-12. Estimated completion is 2006-02.
What interventions are being tested in trial NCT00098280?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT00098280?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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