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

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ClinicalTrials.gov Identifier: NCT03249480
Recruitment Status : Unknown
Verified July 2017 by GeneScience Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborators:
Beijing Children's Hospital
Tianjin Medical University General Hospital
Peking University Third Hospital
China-Japan Friendship Hospital
Dalian Children's Hospital
Xian Children's Hospital
Wuhan Children's Hospital
Fuzhou Children s Hospital
Anhui Provincial Children's Hospital
Hunan Children's Hospital
Shenzhen Children's Hospital
Children's Hospital of Hebei Province
Second Affiliated Hospital of Xi'an Jiaotong University
Zhengzhou Children's Hospital, China
Children's Hospital Of Soochow University
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
The First Affiliated Hospital of Kunming Medical College
Kunming Children's Hospital
The First People's Hospital of Yunnan
Xuzhou Children's Hopspital
Henan Provincal People's Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Affiliated Hospital of Harbin Medical University
The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Union Hospital of Tongji Medical College of HUST
Wuxi Children's Hospital
The Second Affiliated Hospital of Kunming Medical University
Nanjing Children's Hospital
Information provided by (Responsible Party):
GeneScience Pharmaceuticals Co., Ltd.

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Intervention Model: Single Group 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, Open-label, Phase IV Clinical Trial With Different Administration Dosage of PEG Somatropin
Actual Study Start Date : January 2015
Estimated Primary Completion Date : August 2017


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.




Primary Outcome Measures :
  1. Ht SDSca (Height Standard Deviation Score for Chronological Age) [ Time Frame: Baseline ]
    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

  2. Change of yearly growth velocity from baseline to 26 weeks [ Time Frame: Baseline, 26 weeks after initiating treatment ]
    Height velocity calculate by formula

  3. Ht SDSca [ Time Frame: 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 (Height Standard Deviation Score for Bone Age) [ Time Frame: Baseline,26 weeks after initiating treatment ]
  2. IGF-1 SDS (IGF-1 Standard Deviation Score) [ Time Frame: Baseline,26 weeks after initiating treatment ]
  3. IGFBP-3 SDS (IGFBP-3 Standard Deviation Score) [ Time Frame: Baseline,26 weeks after initiating treatment ]
  4. Skeletal maturity [ Time Frame: Baseline,26 weeks after initiating treatment ]
    Skeletal maturity=(Bone Age at 26 weeks-Bone Age at baseline)/treatment duration



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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:

  • 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.

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): NCT03249480


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

  Hide Study Locations
Locations
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China, Anhui
Anhui Provincial Children's Hospital Recruiting
Hefei, Anhui, China
China, Fujian
Fuzhou Children s Hospital Recruiting
Fuzhou, Fujian, China
China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China
China, Hebei
The Second Hospital of Hebei Medical University Recruiting
Shijiangzhuang, Hebei, China
Children's Hospital of Hebei Province Recruiting
Shijiazhuang, Hebei, China
China, Heilongjiang
The First Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
China, Henan
Children's Hospital of Zhengzhou Recruiting
Zhengzhou, Henan, China
Henan Provincal People's Hospital Recruiting
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of TCM Recruiting
Zhengzhou, Henan, China
China, Hubei
Union Hospital, Tongji Medical College, HUST Recruiting
Wuhan, Hubei, China
Wuhan Children's Hospital Recruiting
Wuhan, Hubei, China
China, Hunan
Hunan Children's Hospital Recruiting
Changsha, Hunan, China
China, Jiangsu
Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanjing, Jiangsu, China
Nanjing Children's Hospital Recruiting
Nanjing, Jiangsu, China
Children's Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China
Wuxi Children's Hospital Recruiting
Wuxi, Jiangsu, China
Xuzhou Children's Hpspital Recruiting
Xuzhou, Jiangsu, China
China, Liaoning
Dalian Children's Hospital Recruiting
Dalian, Liaoning, China
China, Shanxi
The Second Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China
Xi'an Children's Hospital Recruiting
Xi'an, Shanxi, China
China, Yunnan
First Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China
Kunming Children's Hospital Recruiting
Kunming, Yunnan, China
Second Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China
The First People's Hospital of Yunnan Province Recruiting
Kunming, Yunnan, China
China
China-Japan Friendship Hospital Recruiting
Beijing, China
Peking University Third Hospital Recruiting
Beijing, China
Shenzhen Children's Hospital Recruiting
Shenzhen, China
Tianjin Medical University General Hospital Recruiting
Tianjin, China
Sponsors and Collaborators
GeneScience Pharmaceuticals Co., Ltd.
Beijing Children's Hospital
Tianjin Medical University General Hospital
Peking University Third Hospital
China-Japan Friendship Hospital
Dalian Children's Hospital
Xian Children's Hospital
Wuhan Children's Hospital
Fuzhou Children s Hospital
Anhui Provincial Children's Hospital
Hunan Children's Hospital
Shenzhen Children's Hospital
Children's Hospital of Hebei Province
Second Affiliated Hospital of Xi'an Jiaotong University
Zhengzhou Children's Hospital, China
Children's Hospital Of Soochow University
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
The First Affiliated Hospital of Kunming Medical College
Kunming Children's Hospital
The First People's Hospital of Yunnan
Xuzhou Children's Hopspital
Henan Provincal People's Hospital
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
First Affiliated Hospital of Harbin Medical University
The Second Hospital of Hebei Medical University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Union Hospital of Tongji Medical College of HUST
Wuxi Children's Hospital
The Second Affiliated Hospital of Kunming Medical University
Nanjing Children's Hospital
Investigators
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Principal Investigator: Chunxiu Gong Beijing Children's Hospital

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Responsible Party: GeneScience Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03249480     History of Changes
Other Study ID Numbers: GenSci 004 CT-GCX
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
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