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

NCT ID: NCT03290235

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2021-09-30

Brief 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.

Conditions

Growth Retardation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEG-somatropin-1

Dosage 0.2mg/kg/w

Group Type: EXPERIMENTAL

PEG-somatropin

Intervention Type: DRUG

Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit

PEG-somatropin-2

Dosage 0.1-0.2mg/kg/w

Group Type: EXPERIMENTAL

PEG-somatropin

Intervention Type: DRUG

Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit

Interventions

PEG-somatropin

Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit

Intervention Type: DRUG

Other Intervention Names

Jintrolong®

Eligibility Criteria

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.

• Minimum Eligible Age: 42 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohua Feng

Role: CONTACT

Phone: 0431-85170552

Email: fengxiaohua@gensci-china.com

References

Hou L, Huang K, Gong C, Luo F, Wei H, Liang L, Du H, Zhang J, Zhong Y, Chen R, Chen X, Pan J, Jin X, Zeng T, Liao W, Liu D, Lan D, Zhu S, Dong Z, Ma H, Yang Y, Xiong F, Lu P, Cheng S, Gu X, Jin R, Liu Y, Wu J, Xu X, Chen L, Dong Q, Pan H, Su Z, Liu L, Luo X, Ni S, Chen Z, Hu Y, Wang C, Liu J, Liu L, Lu B, Wang X, Wang Y, Yang F, Zhang M, Cao L, Liu G, Yao H, Zhan Y, Dai M, Li G, Li L, Liu Y, Wang K, Xiao Y, Zhang X, Dong J, Gu Z, Ying L, Huang F, Liu Y, Liu Z, Ye J, Zhao D, Hu X, Jiang Z, Ye K, Zhu H, Chen S, Chen X, Wan N, Xu Z, Yin Q, Zhang H, Huang X, Yin J, Zhang H, Li P, Yin P, Fu J, Luo X. Long-term Pegylated GH for Children With GH Deficiency: A Large, Prospective, Real-world Study. J Clin Endocrinol Metab. 2023 Jul 14;108(8):2078-2086. doi: 10.1210/clinem/dgad039.

Reference Type: DERIVED

PMID: 36669772 (View on PubMed)

Other Identifiers

GenSci 045 CT-Extension Period

Identifier Type: -

Identifier Source: org_study_id