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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04513171
Study type Interventional
Source Xiamen Amoytop Biotech Co., Ltd.
Contact
Status Completed
Phase Phase 2/Phase 3
Start date December 26, 2018
Completion date July 10, 2023
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