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

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

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.

Study Overview

• Status: Unknown
• Conditions: Growth Retardation
• Intervention / Treatment: Drug: PEG-somatropin

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • TongJi hospital affiliated to TongJi medical college of HuaZhong university of Science & Teconology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG-somatropin-1; Dosage 0.2mg/kg/w	Drug: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit; Other Names: Jintrolong®
EXPERIMENTAL: PEG-somatropin-2; Dosage 0.1-0.2mg/kg/w	Drug: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit; Other Names: Jintrolong®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	When yearly growth velocity of some subject is no more than 2cm/year.	Baseline, every 13 weeks until 130 weeks

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (ACTUAL): September 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 10, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: GenSci 045 CT-Extension Period

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No