NCT04638517

The TELO-SCOPE Study: Attenuating Telomere Attrition With Danazol. Is There Scope to Dramatically Improve Health Outcomes for Adults and Children With Pulmonary Fibrosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: The University of Queensland · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

TELO-SCOPE is a national, multi-centre, double-blind, placebo-controlled, randomised trial which will be conducted in subjects aged \>5 years with a multi-disciplinary diagnosis of pulmonary fibrosis and with age-adjusted telomere length below the 10th centile in adults; and for children (age \< 16 years), a confirmed diagnosis of Dyskeratosis Congenita (DC). Consenting participants who meet all other inclusions and no exclusions will be randomised (n=50, 2:1 (danazol:placebo)) to receive danazol (maximum tolerated dose (up to 800mg daily, two-divided doses) or matched placebo, for 12 months in addition to standard of care background therapy. The primary outcome is change in telomere length at 12 months.

Conditions

• Pulmonary Fibrosis
• Telomere Shortening
• Telomere Disease
• Dyskeratosis Congenita

Interventions

Type	Name	Description
DRUG	Danazol	Danazol up to 800mg daily in two-divided doses.
DRUG	Placebo	Matching placebo.

Timeline

• Start date: 2021-09-07
• Primary completion: 2025-01-16
• Completion: 2025-01-16
• First posted: 2020-11-20
• Last updated: 2025-08-05

Locations

9 sites across 1 country: Australia