Trial · NCT01441037
Danazol for Genetic Bone Marrow and Lung Disorders
NCT01441037, Phase 1, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2018-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Danazol for Genetic Bone Marrow and Lung Disorders. Trials, record NCT01441037. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441037
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Danazol for Genetic Bone Marrow and Lung Disorders
- NCT number
- NCT01441037
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 27 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- Aplastic Anemia
- Interventions
- Danazol
- First posted
- 2011-09-27
- Last updated
- 2018-08-15
- Results first posted
- 2018-07-11
- Limitations and caveats
- After 27 patients were enrolled, the study was halted early, because telomere attrition was reduced in all 12 patients who could be evaluated for the primary end point.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Having Attenuation of Accelerated Telomere Attrition | 24 months | The primary efficacy end point was a 20% reduction in the annual rate of telomere attrition measured at 24 months. The biologic response at 24 months, was defined as a reduction in the telomere length attrition rate to 96 bp per year or less. The normal rate of telomere loss of approximately 60 bp per year. Telomere length was determined with a semiautomated, Clinical Laboratory Improvement Amendments (CLIA)-approved real-time quantitative PCR (qPCR) assay performed in triplicate and validated for human cells |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Having Attenuation of Accelerated Telomere Attrition | 24 months | The analyses included only those subjects who took Danazol | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Having Attenuation of Accelerated Telomere Attrition | Danazol | 12 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Danazol | 27 | |
| Overall Study | COMPLETED | Danazol | 27 | |
| Overall Study | NOT COMPLETED | Danazol | 0 |
Source ClinicalTrials.gov
Adverse events115
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Danazol | 2 | 27 | |
| other | Pallor | Blood and lymphatic system disorders | Danazol | 1 | 27 | |
| other | Palpitations | Cardiac disorders | Danazol | 1 | 27 | |
| other | Tachycardia | Cardiac disorders | Danazol | 1 | 27 | |
| other | Otitis externa | Ear and labyrinth disorders | Danazol | 1 | 27 | |
| other | Scleritis | Eye disorders | Danazol | 1 | 27 | |
| other | Vitreous floaters | Eye disorders | Danazol | 1 | 27 | |
| other | Abdominal distension | Gastrointestinal disorders | Danazol | 2 | 27 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Danazol | 1 | 27 | |
| other | Constipation | Gastrointestinal disorders | Danazol | 3 | 27 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Danazol | 0 | 27 |
| Total, other adverse events | Danazol | 24 | 27 |
| Total, serious adverse events | Danazol | 3 | 27 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01441037
GET https://conductscience.org/api/trials/v1/NCT01441037/events?page=2