Growth Hormone Deficiency Clinical Trial
Official title:
Pegylated Somatropin in the Treatment of Children With Growth Hormone Deficient:A Multicenter, Randomized, Open-label, Controlled Phase Ⅲ Clinical Trial
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02243852 -
Effects of Growth Hormone (GH) Deficiency and Growth Hormone Replacement on Serum Fibroblast Growth Factor 21 (FGF21)
|
N/A | |
Completed |
NCT01440686 -
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT00990340 -
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
|
Phase 4 | |
Completed |
NCT00235599 -
The IGFBP-3 Stimulation Test: A New Tool for the Diagnosis of Growth Hormone Deficiency in Children.
|
N/A | |
Completed |
NCT00149708 -
Consequence of Lifetime Isolated Growth Hormone Deficiency
|
N/A | |
Completed |
NCT00459940 -
The Effects of TZD on Fat Metabolism and Insulin Sensitivity in GH-Replaced GHD Patients
|
N/A | |
Completed |
NCT01157793 -
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood
|
Phase 4 | |
Completed |
NCT00004365 -
Study of Pituitary Size and Function in Familial Dwarfism of Sindh
|
N/A | |
Recruiting |
NCT00227253 -
Chromosome 18 Clinical Research Center
|
||
Recruiting |
NCT04121780 -
Growth Hormone Replacement Therapy for Retried Professional Football Players
|
Phase 2 | |
Completed |
NCT02934399 -
Dynamic Hormone Diagnostics in Endocrine Disease
|
||
Completed |
NCT01090778 -
Diurnal Variation of Exogenous Peptides (GH Puls/Jurgita I)
|
Phase 2 | |
Completed |
NCT01062529 -
Peripheral Metabolic Effects of Somatostatin
|
N/A | |
Completed |
NCT00965484 -
Genotropin Study Assessing Use of Injection Pen
|
Phase 3 | |
Completed |
NCT00616278 -
National Cooperative Growth Study in CKD
|
N/A | |
Completed |
NCT02693522 -
Evaluation of Efficacy and Safety of Recombinant Somatroipn in Patients With Growth Hormone Deficiency
|
Phase 3 | |
Recruiting |
NCT02908958 -
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency
|
Phase 4 | |
Terminated |
NCT01243892 -
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
|
N/A | |
Withdrawn |
NCT00638287 -
Inter-Assay Growth Hormone and IGF-I Variability
|
N/A | |
Completed |
NCT00929799 -
Growth Hormone and Glucose Metabolism
|
Phase 4 |