NCT04513171

Safety and Efficacy of Y-shape Pegylated Somatropin in Growth Hormone Deficiency Children

A Multi-center, Randomized, Positive-control, Phase 2&3 Combined Study of Y-shape Pegylated Somatropin in Prepubertal Children With Growth Hormone Deficiency.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Xiamen Amoytop Biotech Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, open-labeled, positive controlled phase 2\&3 combined study to evaluate the safety and efficacy of weekly Y-shape pegylated somatropin, compared to daily somatropin (Norditropin®), in prepubertal, treatment-naive children with growth hormone deficiency.

Detailed description

This multicenter, randomized, open-labeled, positive controlled study is divided into two stages. The first one is aimed to exploit the optimal dose of Y-shape pegylated somatropin, while the second one is aimed to confirm the efficacy and safety of the study drug. A total of 400 prepubertal children with growth hormone deficiency were expected to enrolled. Subjects will firstly undergo a 52 weeks treatment, and then followed for 5 weeks.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Y-shape pegylated somatropin	Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.
DRUG	Y-shape pegylated somatropin	Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.
DRUG	Y-shape pegylated somatropin	Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
DRUG	Norditropin®	Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
DRUG	Y-shape pegylated somatropin	Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
DRUG	Norditropin	Norditropin 245μg/kg/week, subcutaneous injection, Once daily.

Timeline

• Start date: 2018-12-26
• Primary completion: 2023-06-07
• Completion: 2023-07-10
• First posted: 2020-08-14
• Last updated: 2024-01-24

Locations

1 site across 1 country: China