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, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin

To Evaluate the safety and efficacy of PEG Somatropin in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

Study Overview

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

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

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
  • Shenzhen, China
    • Recruiting
    • Shenzhen Children's Hospital
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University General Hospital
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Provincial Children's Hospital
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • Fuzhou Children s Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-sen Memorial Hospital
  • Hebei
    • Shijiangzhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Children's Hospital of Hebei Province
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The First Affiliated Hospital Of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • The first affiliated hospital of henan university of TCM
    • Zhengzhou, Henan, China
      • Recruiting
      • Children's Hospital of Zhengzhou
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan provincal people's hospital
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union Hospital, Tongji Medical College, HUST
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Children's Hospital
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Hunan Children's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Children's Hospital
    • Suzhou, Jiangsu, China
      • Recruiting
      • Children's Hospital of Soochow University
    • Wuxi, Jiangsu, China
      • Recruiting
      • Wuxi Children's Hospital
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Xuzhou Children's Hpspital
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • Dalian Children's Hospital
  • Shanxi
    • Xi'an, Shanxi, China
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shanxi, China
      • Recruiting
      • Xi'an Children's Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • The First People's Hospital of Yunnan Province
    • Kunming, Yunnan, China
      • Recruiting
      • First Affiliated Hospital of Kunming Medical University
    • Kunming, Yunnan, China
      • Recruiting
      • Kunming Children's hospital
    • Kunming, Yunnan, China
      • Recruiting
      • Second Affiliated Hospital of Kunming Medical University

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:

• 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;
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEG-somatropin; 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.	Biological: PEG-somatropin; 30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSca (Height Standard Deviation Score for Chronological Age)	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
Change of yearly growth velocity from baseline to 26 weeks	Height velocity calculate by formula	Baseline, 26 weeks after initiating treatment
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	26 weeks after initiating treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ht SDSBA (Height Standard Deviation Score for Bone Age)		Baseline,26 weeks after initiating treatment
IGF-1 SDS (IGF-1 Standard Deviation Score)		Baseline,26 weeks after initiating treatment
IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)		Baseline,26 weeks after initiating treatment
Skeletal maturity	Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration	Baseline,26 weeks after initiating treatment

Collaborators and Investigators

• Sponsor: GeneScience Pharmaceuticals Co., Ltd.
• Collaborators: The Second Hospital of Hebei Medical University; Peking University Third Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; China-Japan Friendship Hospital; Henan Provincial People's Hospital; Tianjin Medical University General Hospital; The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; The First Affiliated Hospital of Kunming Medical College; Second Affiliated Hospital of Xi'an Jiaotong University; Beijing Children's Hospital; Children's Hospital of Soochow University; Kunming Children's Hospital; First Affiliated Hospital of Harbin Medical University; Hunan Children's Hospital; Shenzhen Children's Hospital; Nanjing Children's Hospital; Zhengzhou Children's Hospital, China; The Second Affiliated Hospital of Kunming Medical University; Xian Children's Hospital; The First People's Hospital of Yunnan; Children's Hospital of Hebei Province; Wuhan Children's Hospital; Dalian Children's Hospital; Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region; Fuzhou Children s Hospital; Anhui Provincial Children's Hospital; Xuzhou Children's Hopspital; Union Hospital of Tongji Medical College of HUST; Wuxi Women's & Children's Hospital
• Investigators: Principal Investigator: Chunxiu Gong, Beijing Children's Hospital

Publications and helpful links

General Publications

• Chen J, Zhong Y, Wei H, Chen S, Su Z, Liu L, Liang L, Lu P, Chen L, Chen R, Ni S, Wang X, Li L, Wang Y, Xu X, Xiao Y, Yao H, Liu G, Jin R, Cao B, Wu D, Su C, Li W, Qin M, Li X, Luo X, Gong C. Polyethylene glycol recombinant human growth hormone in Chinese prepubertal slow-growing short children: doses reported in a multicenter real-world study. BMC Endocr Disord. 2022 Aug 9;22(1):201. doi: 10.1186/s12902-022-01101-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 15, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: July 1, 2017

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-GCX

Drug and device information, study documents

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