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Danazol for short telomeres in lung transplant recipients
NCT04807309Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jan 2021
- Primary completion
- Nov 2021
- Sponsor
- Brigham and Women's Hospital
- Modality
- Orthosteric Ligands
- Drugs
- danazol
01
Overview
Phase 2, randomised, double-blind trial comparing Danazol with Placebo (2 arms). Primary endpoint: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 at 48 weeks. Planned start Jan 2021; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Danazol
Danazol 200mg orally twice a day
Placebo
Placebo orally twice a day
03
Who it enrols
Adult lung transplant recipients with short telomeres (<10th percentile) who are clinically stable one month post-transplant. Excludes patients with active hepatitis, liver disease, bone marrow transplant history, or those taking androgens.
04
Endpoints
Primary
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary
Occurrence of WBC <2000/µl
Cumulative number of events where WBC < 2000/µl
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