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NCT01441037 · ClinicalTrials.gov registry record · Phase 1
Danazol for Genetic Bone Marrow and Lung Disorders
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01441037 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 27 participants.
The verdict
NCT01441037, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
Background: \- Some people have bone marrow and lung disorders that are caused by genetic problems. These problems often involve damage to the ends of the chromosomes that pass down genes. One of these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make enough blood cells. Currently, doctors use a male hormone-based drug called Danazol to improve bone marrow function and treat aplastic anemia. More information is needed on whether Danazol can help repair the damaged chromosomes that cause aplastic anemia and similar disorders that cause low blood cell counts or lung problems. Objectives: \- To study the safety and effectiveness of Danazol for bone marrow and lung disorders caused by damaged genes. Eligibility: \- Individuals at least 2 years of age who have low blood cell counts or lung fibrosis caused by damaged genes. Design: * Participants will be screened with a physical exam and medical history. Then they will have blood and urine tests, imaging studies, and a lung function test. They will also take a 6-minute walking test and have a bone marrow biopsy. * Participants will receive Danazol to take twice a day for the duration of the study. * Participants will have regular study visits at 6, 12, and 24 months, with blood tests, imaging studies, a lung function test, and a 6-minute walking test. A bone marrow sample will be collected at the 12-month visit. * Participants will remain on the study for up to 2 years. Researchers will follow up with them for 2 years after the end of the study.
Interventions
- DRUG Danazol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-07-19 |
| Est. Completion | 2016-11-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441037
The ClinicalTrials.gov registry entry for NCT01441037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 Danazol is the first listed.
NCT01441037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01441037 about?
NCT01441037 is a clinical study titled "Danazol for Genetic Bone Marrow and Lung Disorders". Background: \- Some people have bone marrow and lung disorders that are caused by genetic problems. These problems often involve damage to the ends of the chromosomes that pass down genes. One of these disorders is aplastic anemia. This is a disorder in which the bone marrow does not make enough bl...
What is the current status of trial NCT01441037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2011-07-19. Estimated completion is 2016-11-14.
What interventions are being tested in trial NCT01441037?
The interventions under investigation include: Danazol (DRUG).
Who is sponsoring clinical trial NCT01441037?
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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