Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Children Growth Hormone Deficiency: A Multicenter, Randomized, Parallel, Dose-control Clinical Trial II

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.

Study Overview

• Status: Unknown
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Biological: PEG-somatropin; Biological: PEG-somatropin

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Recruiting
    • Southwest Hospital, Third Military Medical University
    • Contact: Wei Liao, MD
  • Shanghai, China
    • Recruiting
    • Shanghai Children's Medical Center
    • Contact: Xiaodong Huang, MD
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Deyun Liu, MD
    • Wuhu, Anhui, China
      • Recruiting
      • Wuhu No.1 People's Hospital
      • Contact: Jiayan Pan, MD
  • Fujian
    • Xiamen, Fujian, China
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Qun Lian, MD
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Guangzhou Women And Children's Medical Center
      • Contact: Li Liu, MD
    • Guangzhou, Guangdong, China
      • Recruiting
      • The Third Affiliated Hospital, Sun Yat-sen University
      • Contact: Shunye Zhu, MD
  • Guangxi
    • Nanning, Guangxi, China
      • Recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Dan Lan, MD
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • Harbin Children's Hospital
      • Contact: Hong Yu, MD
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital, Central South University
      • Contact: Lizhi Cao, MD
    • Changsha, Hunan, China
      • Recruiting
      • The second Xiangya Hospital of Central South University
      • Contact: Xingxing Zhang, MD
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • Children's Hospital of Changchun
      • Contact: Jing Liu, MD
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Junhua Dong, MD
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Children's Hospital of ShanDong University
      • Contact: Dongmei Zhao, MD
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chengdu Women and Children's Central Hospital
      • Contact: Xinran Cheng, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Xiaoming Luo, MD
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Children's Hospital ,Zhejiang University School of Medicine
      • Contact: Junfen Fu, PhD
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Mingjuan Dai, MD
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial Hospital of Traditional Chinese Medcine Hospital
      • Contact: Qin Dong
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo Women And Children's Hospital
      • Contact: Jianping Zhang, MD
    • Shaoxing, Zhejiang, China
      • Recruiting
      • Shaoxing Second Hospital
      • Contact: Manyan Zhang, MD
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital of Wenzhou Medical University
      • Contact: Xianjiang Jin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
• According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
• Height velocity (HV) ≤5.0 cm/yr.
• GH provocation tests with two different mechanisms showed that GH peak concentration of the child is < 10.0ng/ml.
• Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
• Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
• The child did not receive the treatment of growth hormone within 6 months.
• Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Exclusion Criteria:

• The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr> the upper limit of normal value).
• The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
• The child is known as hypersensitivity to PEG Somatropin.
• The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
• The child has potential tumor (family history).
• The child has diabetics.
• The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
• The child took part in other clinical trials within 3 months.
• Other conditions are excluded when the investigator preclude the enrollment into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-somatropin; Low dose group, PEG Somatropin 0.14mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.	Biological: PEG-somatropin; High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.; Biological: PEG-somatropin; Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
Experimental: PEG-Somatropin; High dose group, PEG Somatropin 0.2mg/kg/week, subcutaneous use, inject once a week, the duration is 26 weeks.	Biological: PEG-somatropin; High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.; Biological: PEG-somatropin; Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of Height Standard Deviation Score for Chronological Age before and after the treatment (ΔHtSDSCA)	HtSDSCA = (Height at the evaluated time point- the mean value of normal children in the same gender and same age) / the height SD of normal children in the same gender and same age	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HtSDSBA	HtSDSBA = (height at the evaluated time point-the mean value of normal children in the same gender and same age) / height SD of normal children in the same bone age and same gender	26 weeks
Annual height velocity	Annual Growth Velocity (cm/yr) = 12×(Height at the end of treatment-Height at the beginning of treatment)/the treatment duration (month)	26 weeks
Standard Deviation Score of serum IGF-1 (IGF-1 SDS)	IGF-1 SDS = (actual concentration of IGF-1-the median of IGF-1 concentration of normal children in the age and same gender) / SD of IGF-1 concentration of normal children in the same gender and same age	26 weeks
Bone Maturation	Bone Maturation = (BA at the end of treatment-BA at the beginning of treatment)/ the treatment duration (Year)	26 weeks

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: First People's Hospital of Hangzhou; Xiangya Hospital of Central South University; Southwest Hospital, China; Qilu Hospital of Shandong University; Shanghai Children's Medical Center; Third Affiliated Hospital, Sun Yat-Sen University; Second Affiliated Hospital of Wenzhou Medical University; Central South University; Zhejiang Provincial People's Hospital; Shaoxing Second Hospital; The Second Hospital of Anhui Medical University; Guangzhou Women and Children's Medical Center; The Children's Hospital of Zhejiang University School of Medicine; The First Affiliated Hospital of Xiamen University; First Affiliated Hospital of Guangxi Medical University; Zhejiang Provincial Hospital of TCM
• Investigators: Principal Investigator: Junfen Fu, PhD, The Children's Hospital of Zhejiang University School of Medicine

Publications and helpful links

General Publications

• Jiang Z, Chen X, Dong G, Lou Y, Zhang J, Cheng X, Pan J, Liao W, Wu J, Huang X, Jin X, Liu D, Zeng T, Zhu S, Dong Q, Luo X, Lan D, Cao L, Zhang X, Liu J, Dai M, Zhang M, Liu L, Dong J, Zhao D, Ni S, Fu J. Short-term efficacy and safety of a lower dose of polyethylene glycol recombinant human growth hormone in children with growth hormone deficiency: A randomized, dose-comparison study. Front Pharmacol. 2022 Aug 11;13:955809. doi: 10.3389/fphar.2022.955809. eCollection 2022.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: September 20, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Hypothalamic Diseases; Bone Diseases; Bone Diseases, Endocrine; Pituitary Diseases; Dwarfism; Bone Diseases, Developmental; Hypopituitarism; Dwarfism, Pituitary; Endocrine System Diseases
• Other Study ID Numbers: GenSci 004 CT-Zhejiang