NCT03305016

A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

fliGHt: A Multicenter, Phase 3, Open-Label, 26-Week Trial Investigating the Safety, Tolerability and Efficacy of TransCon hGH Administered Once Weekly in Children With GHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: Ascendis Pharma Endocrinology Division A/S · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Australia, and New Zealand.

Conditions

• Growth Hormone Deficiency, Pediatric
• Endocrine System Diseases
• Hormone Deficiency
• Pituitary Diseases

Interventions

Type	Name	Description
DRUG	TransCon hGH	Once weekly subcutaneous injection at a starting dose of 0.24 mg/kg/week

Timeline

• Start date: 2017-11-13
• Primary completion: 2019-03-19
• Completion: 2019-03-19
• First posted: 2017-10-09
• Last updated: 2022-01-04
• Results posted: 2022-01-04

Locations

24 sites across 4 countries: United States, Australia, Canada, New Zealand

Regulatory

• FDA-regulated drug study