NCT03344458

A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial

enliGHten: A Multicenter, Phase 3, Long-Term, Open-Label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children With Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Ascendis Pharma A/S · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with 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, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

Conditions

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

Interventions

Type	Name	Description
DRUG	TransCon hGH	Once weekly subcutaneous injection of TransCon hGH

Timeline

• Start date: 2017-12-19
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2017-11-17
• Last updated: 2024-05-08
• Results posted: 2024-05-08

Locations

42 sites across 11 countries: United States, Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, New Zealand, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study