Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
1 other identifier
interventional
600
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 24, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedJune 16, 2017
November 1, 2016
2.4 years
November 24, 2016
June 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Ht SDSBA
Baseline, 4,12,26 weeks after initiating treatment
Yearly growth velocity
Baseline, 4,12,26 weeks after initiating treatment
IGF-1SDS
Baseline, 4,12,26 weeks after initiating treatment
IGF-1/IGFBP-3 molar ratio
Baseline, 4,12,26 weeks after initiating treatment
Bone age
Baseline, 4,12,26 weeks after initiating treatment
Study Arms (3)
PEG-somatropin
EXPERIMENTALPegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
PEG-somatropin per two weeks
EXPERIMENTALPegylated 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
Jintropin AQ
ACTIVE COMPARATORJintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
Interventions
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
Eligibility Criteria
You may qualify if:
- Subjects are diagnosed as GHD before starting treatment, according to medical history, clinical symptoms and signs, GH provocation tests and imaging and other examinations:
- 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;
- Height velocity (HV) ≤5.0 cm / yr;
- GH provocative tests (with two drugs of different mechanism of action) confirmed plasma GH peak \<10.0 ng / ml;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changchun GeneScience Pharmaceutical Co., Ltd.lead
- Children's Hospital of Fudan Universitycollaborator
- Suzhou Municipal Hospitalcollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- The First Affiliated Hospital of Henan University of Science and Technologycollaborator
- Maternal and Child Health Hospital of Hubei Provincecollaborator
- Nantong Universitycollaborator
Study Sites (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
Jiangsu Provincial Hospital of Chinese Traditional medicine
Nanjingkou, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Suzhou City Hospital
Suzhou, Jiangsu, China
Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Maternal and Child Health Hospital of Tai'an city
Tai’an, Shandong, China
Children's Hospital of Chengdu city
Chengdu, Sichuan, China
People's Hospital of Cixi City
Cixi, Zhejiang, China
First People's Hospital
Hangzhou, Zhejiang, China
First People's Hospital of Jiaxing City
Jiaxing, Zhejiang, China
Jinhua Central Hospital
Jinhua, Zhejiang, China
Jishuitan Hospital of Beijing City
Beijing, China
Peoples' hospital of Inner Mongolia Autonomous Region
Inner Mongolia Autonomous Region, China
General Hospital of Ningxia Medical University
Ningxia Autonomous Region, China
Children's Hospital of Fudan University
Shanghai, China
Related Publications (1)
Sun C, Lu B, Liu Y, Zhang Y, Wei H, Hu X, Hu P, Zhao Q, Liu Y, Ye K, Wang K, Gu Z, Liu Z, Ye J, Zhang H, Zhu H, Jiang Z, Liu Y, Wan N, Yan C, Yin J, Ying L, Huang F, Yin Q, Xi L, Luo F, Cheng R. Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial. Front Endocrinol (Lausanne). 2021 Nov 25;12:779365. doi: 10.3389/fendo.2021.779365. eCollection 2021.
PMID: 34899612DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Feihong Luo, Doctor
Children's Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2016
First Posted
November 29, 2016
Study Start
January 1, 2015
Primary Completion
June 1, 2017
Last Updated
June 16, 2017
Record last verified: 2016-11