NCT02781727

A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Ascendis Pharma Endocrinology Division A/S · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.

Conditions

• Growth Hormone Deficiency, Pediatric
• hGH (Human Growth Hormone)
• Endocrine System Diseases
• Hormones
• Pituitary Diseases

Interventions

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

Timeline

• Start date: 2016-12-13
• Primary completion: 2019-01-17
• Completion: 2019-01-17
• First posted: 2016-05-24
• Last updated: 2022-01-04
• Results posted: 2022-01-04

Locations

53 sites across 14 countries: United States, Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey (Türkiye), Ukraine