Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency

Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency: A Multicenter, Randomized, Open-label, Parallel Phase IV Clinical Trial With Different Administration Frequency of PEG Somatropin

To evaluate the safety and efficacy of PEG Somatropin Injection in the treatment of children with growth hormone deficiency, as well as to study the feasibility of extending the dosing intervals (once per two weeks) of PEG Somatropin Injection.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Jishuitan Hospital of Beijing City
  • Inner Mongolia Autonomous Region, China
    • Recruiting
    • Peoples' hospital of Inner Mongolia Autonomous Region
  • Ningxia Autonomous Region, China
    • Recruiting
    • General Hospital of Ningxia Medical University
  • Shanghai, China
    • Recruiting
    • Children's Hospital of Fudan University
    • Contact: Feihong Luo, Doctor; Phone Number: 18017590900; Email: luo_fh@163.com
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Maternal and Child Health Hospital of Anhui province
    • Lu'an, Anhui, China
      • Recruiting
      • First People's Hospital of Lu'an City
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • Second Hospital of Lanzhou University
  • Guizhou
    • Guiyangtou, Guizhou, China
      • Recruiting
      • Maternal and Child Health Hospital of Guiyang City
  • Hainan
    • Haikou, Hainan, China
      • Recruiting
      • Maternal and Child Health Hospital of Hainan Province
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Hebei Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Henan University of Science and Technology
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Maternal and Child Health Hospital of Hubei Province
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Recruiting
      • First People's Hospital of Changzhou City
    • Lianyungang, Jiangsu, China
      • Recruiting
      • First People's Hospital of Lianyungang City
    • Nanjingkou, Jiangsu, China
      • Recruiting
      • Jiangsu Provincial Hospital of Chinese Traditional medicine
    • Nantong, Jiangsu, China
      • Recruiting
      • Affiliated Hospital of Nantong University
    • Suzhou, Jiangsu, China
      • Recruiting
      • Suzhou City Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Second Affiliated Hospital of Nanchang University
  • Shandong
    • Tai'an, Shandong, China
      • Recruiting
      • Maternal and Child Health Hospital of Tai'an city
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Children's Hospital of Chengdu city
  • Zhejiang
    • Cixi, Zhejiang, China
      • Recruiting
      • People's Hospital of Cixi City
    • Hangzhou, Zhejiang, China
      • Recruiting
      • First People's Hospital
    • Jiaxing, Zhejiang, China
      • Recruiting
      • First People's Hospital of Jiaxing City
    • Jinhua, Zhejiang, China
      • Recruiting
      • Jinhua Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:

  1. According to statistical height data of physical development of Chinese children in nine cities in 2005, the height is lower than 3rd percentile growth curve of the same age, same sex normal children;
  2. Height velocity (HV) ≤5.0 cm / yr;
  3. GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak <10.0 ng / ml;
  4. bone age for girl≤9 years old, for Boy≤10 years old, bone age is one year or more later than the actual age, that is the actual age - bone age ≥ 1 year;
• Before puberty (Tanner I stage), age≥3 years old, male or female;
• Subjects have not received hormone therapy within 6 months;
• 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:

• Dysfunction of liver and kidney (ALT> 2 times the upper limit of normal, Cr> upper limit of normal);
• Patients positive for hepatitis B c-antibody (HBcAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg);
• 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;
• Potential cancer patients (family history);
• Patients with diabetics;
• Patients with other growth disorders, such as Turner's syndrome, sexual physical delayed puberty, Laron syndrome, growth hormone receptor deficiency, girls with slowly growing who did not rule out chromosomal abnormalities;
• Patients with congenital bone dysplasia or scoliosis;
• Subjects took part in other clinical trial study during 3 months;
• Other conditions in which the investigator preclude enrollment into the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks	Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks; Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
EXPERIMENTAL: PEG-somatropin per two weeks; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks	Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks; Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
ACTIVE_COMPARATOR: Jintropin AQ; Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks	Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks; Biological: PEG-somatropin; Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSca	Ht SDSca was 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, 4,12,26 weeks after initiating treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSBA	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Yearly growth velocity	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
IGF-1SDS	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
IGF-1/IGFBP-3 molar ratio	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Bone age	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: Children's Hospital of Fudan University; The First Affiliated Hospital of Henan University of Science and Technology; General Hospital of Ningxia Medical University; Nantong University; Maternal and Child Health Hospital of Hubei Province; Suzhou Municipal Hospital

Publications and helpful links

General Publications

• Sun C, Lu B, Liu Y, Zhang Y, Wei H, Hu X, Hu P, Zhao Q, Liu Y, Ye K, Wang K, Gu Z, Liu Z, Ye J, Zhang H, Zhu H, Jiang Z, Liu Y, Wan N, Yan C, Yin J, Ying L, Huang F, Yin Q, Xi L, Luo F, Cheng R. Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. Front Endocrinol (Lausanne). 2021 Nov 25;12:779365. doi: 10.3389/fendo.2021.779365. eCollection 2021. Erratum In: Front Endocrinol (Lausanne). 2021 Dec 28;12:830469.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 24, 2016
• First Posted (ESTIMATE): November 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2017
• Last Update Submitted That Met QC Criteria: June 14, 2017
• Last Verified: November 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-4