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

NCT03290235 | Unknown Phase 4

• 1 other identifier: GenSci 045 CT-Extension Period
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Ht SDSBA (Height standard deviation score for bone age)

  Baseline, every 13 weeks until 130 weeks

• Yearly growth velocity

  Baseline, every 13 weeks until 130 weeks

• IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)

  Baseline, every 13 weeks until 130 weeks

• Bone age

  Baseline, 26 weeks, 52 weeks, 78 weeks, 104 weeks, 130 weeks

• Near final height for some subjects

  Baseline, every 13 weeks until 130 weeks

Study Arms (2)

PEG-somatropin-1

EXPERIMENTAL

Dosage 0.2mg/kg/w

Drug: PEG-somatropin

PEG-somatropin-2

EXPERIMENTAL

Dosage 0.1-0.2mg/kg/w

Drug: PEG-somatropin

Interventions

PEG-somatropin DRUG

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

Also known as: Jintrolong®

PEG-somatropin-1; PEG-somatropin-2

Eligibility Criteria

• Age: 42 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

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

Wuhan, Hubei, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36669772 DERIVED

Central Study Contacts

Xiaohua Feng

CONTACT

0431-85170552; fengxiaohua@gensci-china.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: March 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: September 1, 2021
• Last Updated: December 12, 2017

Record last verified: 2017-09

Locations

CN (1)