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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT01342146 |
Date of registration:
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21/04/2011 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children
PD |
Scientific title:
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Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study |
Date of first enrolment:
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May 2006 |
Target sample size:
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101 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01342146 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Contacts
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Name:
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Xiaoping Luo, Doctor |
Address:
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Telephone:
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Email:
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Affiliation:
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Tongji Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- have a height less than two standard deviations (SD) below the median height for
individuals of the same age or height, a growth velocity (GV) =4 cm/yr, a GH peak
concentration <7 ng/ml in two different provocative tests, a bone age (BA; =9 years in
girls and =10 years in boys) at least 2 years less than his/her chronological age
(CA);
- be in preadolescence (Tanner stage 1) and have a CA >3 years;
- have a height value recorded 3 months before the start of GH treatment to calculate
pre-treatment GV;
- receive no prior GH treatment.
- sign informed consent
Exclusion Criteria:
- patients with severe cardiopulmonary
- patients with hematological diseases
- a current or past history of malignant tumors
- immunodeficiency diseases
- mental diseases
- patients positive for hepatitis B e-antibody (HBeAb)
- hepatitis B surface antigen (HBsAg)
- hepatitis B e antigen (HBeAg)
- patients with other growth disorders, such as Turner syndrome
- constitutional delay of growth and puberty, and Laron syndrome
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Drug: Jintropin AQ
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Drug: pegylated Somatropin
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Primary Outcome(s)
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Growth velocity
[Time Frame: 25 weeks]
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Secondary Outcome(s)
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height standard deviation score for chronological age (Ht SDSCA)
[Time Frame: 25 weeks]
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IGF-1
[Time Frame: 25 weeks]
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IGFBP3
[Time Frame: 25 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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