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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03249480
• Other study ID #: GenSci 004 CT-GCX
• Status: Recruiting
• Phase: Phase 4
• First received: July 24, 2017
• Last updated: August 10, 2017
• Start date: January 2015

Study information

• Verified date: July 2017
• 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 in the treatment of children with growth hormone deficiency, as well as to study the dosage of PEG Somatropin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• PEG-somatropin
30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.

Locations

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

Sponsors (30)

Lead Sponsor

Collaborator

GeneScience Pharmaceuticals Co., Ltd.

Anhui Provincial Children's Hospital, Beijing Children's Hospital, Children's Hospital of Hebei Province, Children's Hospital Of Soochow University, Children's Hospital of Zhengzhou, China-Japan Friendship Hospital, Dalian Children's Hospital, First Affiliated Hospital of Harbin Medical University, Fuzhou Children s Hospital, Henan Provincal People's Hospital, Hunan Children's Hospital, Kunming Children's Hospital, Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region, Nanjing Children's Hospital, Peking University Third Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Shenzhen Children's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital of Kunming Medical College, The First People's Hospital of Yunnan, The Second Affiliated Hospital of Kunming Medical University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Union Hospital of Tongji Medical College of HUST, Wuhan Children's Hospital, Wuxi Children's Hospital, Xi'an Children's Hospital, Xuzhou Children's Hopspital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change of yearly growth velocity from baseline to 26 weeks	Height velocity calculate by formula	Baseline, 26 weeks after initiating treatment
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	26 weeks after initiating treatment
Secondary	Ht SDSBA (Height Standard Deviation Score for Bone Age)		Baseline,26 weeks after initiating treatment
Secondary	IGF-1 SDS (IGF-1 Standard Deviation Score)		Baseline,26 weeks after initiating treatment
Secondary	IGFBP-3 SDS (IGFBP-3 Standard Deviation Score)		Baseline,26 weeks after initiating treatment
Secondary	Skeletal maturity	Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration	Baseline,26 weeks after initiating treatment