NCT02976675

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	PEG-somatropin	Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
BIOLOGICAL	PEG-somatropin	Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-06-01
• First posted: 2016-11-29
• Last updated: 2017-06-16

Locations

24 sites across 1 country: China