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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02314676 |
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Date of registration:
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27/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase IV Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
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Scientific title:
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Date of first enrolment:
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November 2014 |
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Target sample size:
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900 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02314676 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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China
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Contacts
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Name:
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Junfen Fu, Ph.D |
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Address:
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Telephone:
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13777457849 |
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Email:
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fjf68@qq.com |
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Affiliation:
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Name:
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Junfen Fu, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital Affiliated to Medical College of Zhejiang University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 B e 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.
- Potential tumor patients (family history).
- Diabetic.
- 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.
Age minimum:
3 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dwarfism, Pituitary
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Intervention(s)
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Biological: PEG-somatropin
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Primary Outcome(s)
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Actual height of the patient after treatment compared with the mean height of the population and the standard deviation (SD) of the height of the population for that chronological age
[Time Frame: 26 weeks]
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Secondary ID(s)
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GenSci 004 CT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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