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

Phase 4

• Conditions: Growth Hormone Deficiency

• Registration Number: NCT02976675
• Lead Sponsor: Changchun GeneScience Pharmaceutical 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-29
• Primary Completion: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ht SDSca	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

Name	Time	Method
IGF-1/IGFBP-3 molar ratio	Baseline, 4,12,26 weeks after initiating treatment	Calculate by formula
Bone age	Baseline, 4,12,26 weeks after initiating treatment	Calculate by formula
Ht SDSBA	Baseline, 4,12,26 weeks after initiating treatment	Calculate by formula
Yearly growth velocity	Baseline, 4,12,26 weeks after initiating treatment	Calculate by formula
IGF-1SDS	Baseline, 4,12,26 weeks after initiating treatment	Calculate by formula

Trial Locations

Locations (24)

Maternal and Child Health Hospital of Anhui province; 🇨🇳 Hefei, Anhui, China

First People's Hospital of Lu'an City; 🇨🇳 Lu'an, Anhui, China

Second Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Maternal and Child Health Hospital of Guiyang City; 🇨🇳 Guiyangtou, Guizhou, China

Maternal and Child Health Hospital of Hainan province; 🇨🇳 Haikou, Hainan, China

Hebei Provincial People's Hospital; 🇨🇳 Shijiazhuang, Hebei, China

First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Zhengzhou, Henan, China

Maternal and Child Health Hospital of Hubei province; 🇨🇳 Wuhan, Hubei, China

First People's Hospital of Changzhou City; 🇨🇳 Changzhou, Jiangsu, China

First People's Hospital of Lianyungang City; 🇨🇳 Lianyungang, Jiangsu, China

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