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

Growth Hormone Deficiency Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02976675
• Other study ID #: GenSci 004 CT-4
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2016
• Last updated: June 14, 2017
• Start date: January 2015

Study information

• Verified date: November 2016
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: Xiaohua Feng
• Phone: 13610794989
• Email: fengxiaohua[@]gensci-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

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
• 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

Locations

Country	Name	City	State
China	Jishuitan Hospital of Beijing City	Beijing
China	First People's Hospital of Changzhou City	Changzhou	Jiangsu
China	Children's Hospital of Chengdu city	Chengdu	Sichuan
China	People's Hospital of Cixi City	Cixi	Zhejiang
China	Maternal and Child Health Hospital of Guiyang City	Guiyangtou	Guizhou
China	Maternal and Child Health Hospital of Hainan province	Haikou	Hainan
China	First People's Hospital	Hangzhou	Zhejiang
China	Maternal and Child Health Hospital of Anhui province	Hefei	Anhui
China	Peoples' hospital of Inner Mongolia Autonomous Region	Inner Mongolia Autonomous Region
China	First People's Hospital of Jiaxing City	Jiaxing	Zhejiang
China	Jinhua Central Hospital	Jinhua	Zhejiang
China	Second Hospital of Lanzhou University	Lanzhou	Gansu
China	First People's Hospital of Lianyungang City	Lianyungang	Jiangsu
China	First People's Hospital of Lu'an City	Lu'an	Anhui
China	Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Provincial Hospital of Chinese Traditional medicine	Nanjingkou	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	General Hospital of Ningxia Medical University	Ningxia Autonomous Region
China	Children's Hospital of Fudan University	Shanghai
China	Hebei Provincial People's Hospital	Shijiazhuang	Hebei
China	Suzhou City Hospital	Suzhou	Jiangsu
China	Maternal and Child Health Hospital of Tai'an city	Tai'an	Shandong
China	Maternal and Child Health Hospital of Hubei province	Wuhan	Hubei
China	First Affiliated Hospital of Henan University of Science and Technology	Zhengzhou	Henan

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ht SDSBA	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Secondary	Yearly growth velocity	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Secondary	IGF-1SDS	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Secondary	IGF-1/IGFBP-3 molar ratio	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment
Secondary	Bone age	Calculate by formula	Baseline, 4,12,26 weeks after initiating treatment