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NCT00229619 · ClinicalTrials.gov registry record · Phase 2
Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia
A Phase 2 study of Anemia, Aplastic and Anemia, Diamond-Blackfan, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT00229619: Completed Phase 2 study of Anemia, Aplastic and Anemia, Diamond-Blackfan, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT00229619 is a Phase 2 study of Anemia, Aplastic and Anemia, Diamond-Blackfan that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 11 participants, below the 539-participant average among 5 other Anemia, Aplastic trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00229619, a Phase 2 study of Anemia, Aplastic and Anemia, Diamond-Blackfan, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test whether the immune-suppressing drug rituximab can increase blood counts and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the immune system turns against bone marrow cells, causing the bone marrow to stop producing red blood cells in patients with pure red cell aplasia and Diamond Blackfan anemia, and red blood cells, white blood cells and platelets in patients with aplastic anemia. Rituximab is a laboratory-made monoclonal antibody that recognizes and destroys white blood cells called lymphocytes that are responsible for destroying bone marrow cells in these diseases. The drug is currently approved by the Food and Drug Administration for treating patients with B-cell non-Hodgkin lymphoma, a disease of white blood cells.
Primary Outcome
Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses. Primary endpoint will determine immune response by evaluating changes in peripheral blood counts (platelets, ab
Conditions Studied
Interventions
- DRUG Rituximab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2005-09 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
What the finished NCT00229619 record still lists
NCT00229619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 539-participant average among 5 other Anemia, Aplastic trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Anemia, Aplastic appearing as the primary indexed condition, and to 1 intervention - of which Rituximab is the first listed.
NCT00229619 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00229619 about?
NCT00229619 is a clinical study titled "Rituximab to Treat Moderate Aplastic Anemia, Pure Red Cell Aplasia, or Diamond Blackfan Anemia". This study will test whether the immune-suppressing drug rituximab can increase blood counts and reduce the need for transfusions in patients with moderate aplastic anemia, pure red cell aplasia, or Diamond Blackfan anemia. These are rare and serious blood disorders in which the immune system turns ...
What is the current status of trial NCT00229619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2005-09. Estimated completion is 2010-06.
What conditions does trial NCT00229619 study?
This clinical trial studies the following conditions: Anemia, Aplastic, Anemia, Diamond-Blackfan, Red-Cell Aplasia, Pure.
What interventions are being tested in trial NCT00229619?
The interventions under investigation include: Rituximab (DRUG).
Who is sponsoring clinical trial NCT00229619?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00229619 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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