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

Phase 4

• Conditions: Growth Retardation
• Interventions: Drug: PEG-somatropin

• Registration Number: NCT03290235
• Lead Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Status Verified: 2017-09
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Last Update Submitted: 2017-12-10
• Last Update Posted: 2017-12-12
• Primary Completion: 2020-10
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG-somatropin-1	PEG-somatropin	Dosage 0.2mg/kg/w
PEG-somatropin-2	PEG-somatropin	Dosage 0.1-0.2mg/kg/w

Primary Outcome Measures

Name	Time	Method
Ht SDSca (Height standard deviation score for chronological age)	Baseline, every 13 weeks until 130 weeks	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

Secondary Outcome Measures

Name	Time	Method
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	When yearly growth velocity of some subject is no more than 2cm/year.
IGF-1 SDS (Standard deviation score of insulin-like growth factor-1)	Baseline, every 13 weeks until 130 weeks
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

Trial Locations

Locations (1)

TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology; 🇨🇳 Wuhan, Hubei, China