- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01495468
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Beijing, China
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Changchun, China
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Guangzhou, China
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Hangzhou, China
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Shanghai, China
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Wu Han, China
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 1. Subjects have a height less than two standard deviations (SD) below the median height for individuals of he same age or height,the growth velocity (CV≤4.0 cm/yr),GH peak concentration <7.0ng/ml in two difference provocative tests, Bone age (BA) ≤9 years in girls and ≤10 years in boys, at least 2 year 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:
- 1. patients positive for hepatitis B e-antibody (HBeAb), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg)
- 2.Known hypersensitivity to Somatropin or any other components of the study product.
- 3. severe cardiopulmonary or hematological diseases, a current or past history of malignant tumors, immunodeficiency diseases, or mental diseases
- 4. with other growth disorders, such as Turner syndrome, constitutional delay of growth and puberty, and Laron syndrome
- 5. Subjects took part in other clinical trial study during 3 months.
- 6. Other conditions which in the opinion of the investigator preclude enrollment into the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
yearly growth velocity
Time Frame: 6 months
|
growth velocity add as GV was the primary outcome measure
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
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IGF-l
Time Frame: 6 months
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6 months
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IGFBP-3
Time Frame: 6 months
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6 months
|
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bone maturity
Time Frame: 6 months
|
6 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Xiaoping Luo, Ph. D, Tongji Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Musculoskeletal Diseases
- Hypothalamic Diseases
- Bone Diseases
- Bone Diseases, Endocrine
- Pituitary Diseases
- Dwarfism
- Bone Diseases, Developmental
- Hypopituitarism
- Dwarfism, Pituitary
- Endocrine System Diseases
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormones
Other Study ID Numbers
- GenSci-004-CT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Growth Hormone Deficiency
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Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyFrance
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Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyDenmark
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Novo Nordisk A/SCompletedGrowth Hormone Disorder | Adult Growth Hormone DeficiencyGermany
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Novo Nordisk A/SWithdrawnGrowth Hormone Disorder | Growth Hormone Deficiency in Children
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Teva Pharmaceutical Industries, Ltd.TerminatedGrowth Hormone-DeficiencyBelarus, Bulgaria, Georgia, Greece, Hungary, Israel, Poland, Romania, Russian Federation, Serbia, Spain, Turkey, Ukraine
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OPKO Health, Inc.CompletedSafety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient ChildrenPediatric Growth Hormone DeficiencyGreece, Hungary, Slovakia
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Novo Nordisk A/SCompletedGrowth Hormone Disorder | Growth Hormone Deficiency in Children | Delivery SystemsGermany, Netherlands, Sweden
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OPKO Health, Inc.CompletedAdult Growth Hormone DeficiencyCzechia, Hungary, Israel, Serbia, Slovakia, Slovenia
Clinical Trials on PEG-somatropin
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GeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University; The First Hospital of Jilin University and other collaboratorsUnknownSmall for Gestational Age InfantChina
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GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsActive, not recruiting
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GeneScience Pharmaceuticals Co., Ltd.First People's Hospital of Hangzhou; Xiangya Hospital of Central South University and other collaboratorsUnknownGrowth Hormone DeficiencyChina
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GeneScience Pharmaceuticals Co., Ltd.Unknown
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GeneScience Pharmaceuticals Co., Ltd.Huazhong University of Science and TechnologyCompleted
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Changchun GeneScience Pharmaceutical Co., Ltd.Not yet recruiting
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GeneScience Pharmaceuticals Co., Ltd.The Second Hospital of Hebei Medical University; Peking University Third Hospital and other collaboratorsUnknownGrowth Hormone DeficiencyChina
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GeneScience Pharmaceuticals Co., Ltd.Children's Hospital of Fudan University; The First Affiliated Hospital of Henan... and other collaboratorsUnknownGrowth Hormone DeficiencyChina
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GeneScience Pharmaceuticals Co., Ltd.UnknownGrowth Hormone DeficiencyChina
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GeneScience Pharmaceuticals Co., Ltd.First Affiliated Hospital, Sun Yat-Sen University; Huazhong University of Science... and other collaboratorsCompletedEfficiency and Safety Study of Pegylated Somatropin to Treat Growth Hormone Deficiency Children (PD)Growth Hormone Deficiency