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Trial record 4 of 821 for:    SOMATROPIN

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

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ClinicalTrials.gov Identifier: NCT02976675
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 16, 2017
Sponsor:
Collaborators:
Children's Hospital of Fudan University
Suzhou Municipal Hospital
General Hospital of Ningxia Medical University
The First Affiliated Hospital of Henan University of Science and Technology
Maternal and Child Health Hospital of Hubei Province
Nantong University
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency Biological: PEG-somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Estimated Primary Completion Date : June 2017


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



Primary Outcome Measures :
  1. Ht SDSca [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    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


Secondary Outcome Measures :
  1. Ht SDSBA [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Calculate by formula

  2. Yearly growth velocity [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Calculate by formula

  3. IGF-1SDS [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Calculate by formula

  4. IGF-1/IGFBP-3 molar ratio [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Calculate by formula

  5. Bone age [ Time Frame: Baseline, 4,12,26 weeks after initiating treatment ]
    Calculate by formula



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976675


Contacts
Contact: Xiaohua Feng 13610794989 fengxiaohua@gensci-china.com

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

Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02976675     History of Changes
Other Study ID Numbers: GenSci 004 CT-4
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs