Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
NCT ID: NCT02976675
Last Updated: 2017-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
600 participants
INTERVENTIONAL
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pegylated Somatropin (PEG Somatropin) in the Treatment of Children With Growth Hormone Deficiency
NCT03249480
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
NCT02314676
Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
NCT01342146
Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
NCT02380235
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
NCT01495468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PEG-somatropin
Pegylated 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
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
PEG-somatropin per two weeks
Pegylated 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
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
Jintropin AQ
Jintropin AQ, injection, 30IU/10 mg/3ml/cartridge, 0.25mg/kg/w, once per day for 26 weeks
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
* 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.
3 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Children's Hospital of Fudan University
OTHER
Suzhou Municipal Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Maternal and Child Health Hospital of Hubei Province
OTHER
Nantong University
OTHER
Changchun GeneScience Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Feihong Luo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GenSci 004 CT-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.