Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children (Clinical Trial I)
1 other identifier
interventional
600
1 country
12
Brief Summary
This study evaluates the safety and efficiency of Pegylated Somatropin (PEG Somatropin) Injection in the treatment of endogenous growth hormone deficiency (GHD) in the broad of population of children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2014
Typical duration for phase_4
12 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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 2, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 16, 2017
June 1, 2017
2.5 years
March 2, 2015
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
Study Arms (2)
PEG-somatropin
EXPERIMENTAL0.12mg/kg/w
PEG-Somatropin
EXPERIMENTAL0.20mg/kg/w
Interventions
Eligibility Criteria
You may qualify if:
- Before starting treatment, according to the medical history, clinical symptoms and signs, GH stimulation test and imaging examination, patients are diagnosed as GHD.
- According to the height statistical data of Chinese children's physique development in nine cities in 2005,height is lower than the third percentile of growth curve of normal children with the same age and gender.
- Height velocity (HV) ≤5.0 cm/yr.
- GH stimulation test with two different mechanisms affirms that GH peak concentration of patients' plasma\<10.0ng/ml.
- Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 1 year less than his/her chronological age (CA).
- Be in preadolescence (Tanner stage 1) and have a CA ≧ 3 years.
- Receive no prior GH treatment within 6 months.
- Sign informed consent.
You may not qualify if:
- People with abnormal liver or kidney function (ALT\> 2 times the upper limit of normal value, Cr\> the upper limit of normal value).
- Patients positive for hepatitis B core antigen (HBc), hepatitis B surface antigen (HBsAg) or hepatitis Be antigen (HBeAg).
- People with known highly allergic constitution or allergy to the drug of the study.
- People with severe cardiopulmonary, hematological and malignant tumors diseases or general infection and immune deficiency.
- Diabetic.
- Potential tumor patients (family history).
- Abnormal growth and development, such as Turner syndrome, constitutional delay of growth and puberty,Laron syndrome, growth hormone receptor deficiency, girls of growth retardation without excluding abnormal chromosome.
- Subjects took part in other clinical trial study within 3 months.
- Other conditions which in the opinion of the investigator preclude enrollment into the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Children's Hospital Affiliated to Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Chinese Academy of Medical Sciences &Peking Union Medical College
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Affiliated Hospital, Jiangnan University
Wuxi, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Children's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
West China Second University Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
March 2, 2015
First Posted
March 5, 2015
Study Start
December 1, 2014
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
June 16, 2017
Record last verified: 2017-06