Extension Study of Pegylated Somatropin to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Growth Retardation Clinical Trial

Official title:

The Extension Study of Phase IV Clinical Trial of Pegylated Somatropin (PEG Somatropin) to Treat Growth Retardation Caused by Endogenous Growth Hormone Deficiency in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03290235
• Other study ID #: GenSci 045 CT-Extension Period
• Status: Recruiting
• Phase: Phase 4
• First received: September 19, 2017
• Last updated: December 10, 2017
• Start date: March 1, 2017
• Est. completion date: September 2021

Study information

• Verified date: September 2017
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 0431-85170552
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

1. To further evaluate the safety and efficacy of PEG-Somatropin in the treatment of children with growth hormone deficiency for a relatively long period

2. To explore the factors influencing the efficacy of PEG-Somatropin and to establish the height prediction model based on Chinese children with short stature, and to provide the basis and guidance for standard and reasonable long-term clinical application of PEG-Somatropin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Months to 15 Years

Eligibility

Inclusion Criteria:

• Children has completed all visits and therapy in previous phase IV study;

• Investigators evaluate subjects could continue growth hormone therapy;

• Subjects is willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent.

Exclusion Criteria:

• Children with epiphyseal closure;

• Children is near the adule final height, that is, growth rate= 2 cm / year or bone age = 14 years old for girls, bone age = 16 years old for boys;

• Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);

• Patients with known hypersensitivity to PEG-Somatropin or Somatropin or any other components of the study product;

• Patients with severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases;

• Patients with diabetics;

• Patients with congenital bone dysplasia or scoliosis;

• Patients took drugs that would influence the efficacy and safety of PEG-Somatropin after phase IV study and before screening for this extension study;

• Other conditions in which the investigator preclude enrollment into the study.

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Retardation

Intervention

Drug:
• PEG-somatropin
Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit

Locations

Country	Name	City	State
China	TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ht SDSca (Height standard deviation score for chronological age)	Calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age	Baseline, every 13 weeks until 130 weeks
Secondary	Ht SDSBA (Height standard deviation score for bone age)		Baseline, every 13 weeks until 130 weeks
Secondary	Yearly growth velocity		Baseline, every 13 weeks until 130 weeks
Secondary	IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)		Baseline, every 13 weeks until 130 weeks
Secondary	Bone age		Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks
Secondary	Near final height for some subjects	When yearly growth velocity of some subject is no more than 2cm/year.	Baseline, every 13 weeks until 130 weeks