The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically… (NCT04638517) | Clinical Trial Compass
TerminatedPhase 2
The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis
Stopped: Data Safety Monitoring Board recommended cessation due to futility
Australia29 participantsStarted 2021-09-07
Plain-language summary
TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised (2:1) trial which will test the hypothesis that, compared to placebo, the addition of danazol to standard of care in pulmonary fibrosis associated with short telomeres is safe and will result in reduced telomere attrition.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. Males and females aged \>5 years, able to take capsules orally.
✓. Fibrosing interstitial pneumonia (Idiopathic PF, idiopathic non-specific interstitial pneumonia, chronic hypersensitivity pneumonitis, pleuroparenchymal fibroelastosis, unclassifiable interstitial lung disease (ILD)) diagnosed according to the current international guidelines.
✓. If receiving background pirfenidone / nintedanib, stable dose for 28 days prior to screening.
✓. Able to understand and sign a written informed consent form (or legally authorised representative).
✓. Agreement to use a medically approved form of non-hormonal contraception (if of child-bearing potential) (noting that oral contraceptives are advised not to be used concurrently with danazol).
Exclusion criteria
What they're measuring
1
Change in absolute telomere length from baseline (base pairs)