Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
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|ClinicalTrials.gov Identifier: NCT01495468|
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : July 31, 2017
This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).
All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.
Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency||Biological: PEG-somatropin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||343 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient：A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||March 2008|
- Biological: PEG-somatropin
drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 monthsOther Names:
- recombinant human growth hormone
- peglyated growth hormone
- yearly growth velocity [ Time Frame: 6 months ]growth velocity add as GV was the primary outcome measure
- Ht SDSca [ Time Frame: 6 months ]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
- IGF-l [ Time Frame: 6 months ]
- IGFBP-3 [ Time Frame: 6 months ]
- bone maturity [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495468
|Wu Han, China|
|Principal Investigator:||Xiaoping Luo, Ph. D||Tongji Hospital|