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Lack of financial support
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To evaluate the safety and efficacy of Danzol in lung transplant recipients with short telomeres.
Subjects with short telomeres recipient of lung transplant, will be randomized in the first month post-transplant to either placebo or Danazol (200mg bid) in a 2:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo comparison |
|
| Danazol Pill | Active Comparator | Danazol 200mg orally twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danazol Pill | Drug | Danazol 200 mg orally twice a day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The incidence, severity, outcome, and relationship to study treatment of adverse events and serious adverse events. Change from baseline in clinical laboratory test results. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of WBC <2000/µl | -Occurrence of WBC <2000/µl at any time during study period. | 48 weeks |
| Cumulative number of events where WBC < 2000/µl | - Evaluating cumulative number of events where WBC < 2000/µl |
| Measure | Description | Time Frame |
|---|---|---|
| Telomere length | -Measure change in lymphocyte telomere length at end of study drug administration compared to screening | 48 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D007970 | Leukopenia |
| ID | Term |
|---|---|
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D003613 | Danazol |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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Randomized double blind 2:1 ratio
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Similar tablets will be generated.
| Drug |
Placebo twice a day |
|
| 48 weeks |
| D011083 |
| Polycyclic Compounds |