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| Name | Class |
|---|---|
| University of Glasgow | OTHER |
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In order to further observe the long-term safety and effectiveness of real-world polyethylene glycol-recombinant human growth hormone(PEG-rhGH) treatment of GHD, idiopathic short stature, and SGA in children, explore and analyze the factors affecting the efficacy of PEG-rhGH and the height prediction model after treatment, etc., collect and analyze more scientifically and rationally, and understand the situation of real-world PEG-GH treatment. A database registration study was developed.
A database registration study was developed to retrospectively analyze the efficacy and safety of polyethylene glycol recombinant human growth hormone injection in the treatment of slow growth in children caused by endogenous growth hormone deficiency, idiopathic short stature, Turner syndrome, etc., and to further prospectively follow up and monitor. In order to participate in the global real-world use of long-acting growth hormone, all data from this study were uploaded to the Global Registry of New Therapies for Rare Endocrine Diseases and Bone Disorders (GloBE-Reg) platform.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| growth hormone deficiency(GHD) | Growth hormone deficiency (GHD) is a rare and treatable condition that causes short height in children and metabolic issues in adults. |
| |
| Idiopathic short stature (ISS) | Idiopathic short stature is a condition in which the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population, in whom no identifiable disorder is present. |
| |
| small for gestational age (SGA) | Small for gestational age (SGA) is defined as a birth weight of less than 10th percentile for gestational age. |
| |
| Turner Syndrome (TS) | Turner syndrome, a condition that affects only females, results when one of the X chromosomes (sex chromosomes) is missing or partially missing. |
| |
| others | others who with the height of the individual is more than 2 SD below the corresponding mean height for a given age, sex and population. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyethylene glycol recombinant human growth hormone injection | Drug | 0.1-0.3mg/kg.w |
|
| Measure | Description | Time Frame |
|---|---|---|
| the change in height standard deviation score | final adult height standard deviation score- height standard deviation score before treatment | 3-10years |
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Inclusion Criteria:
Patients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection
Exclusion Criteria:
Patients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;
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The height of the patients was below 2 stadard deviation below average. The patients were diagosesed as endogenous growth hormone deficiency, TS, SGA, ISS, etc. and treated with polyethylene glycol recombinant human growth hormone injection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunxiu Gong, Dr. | Contact | 13370115001 | chunxiugong@163.com | |
| Jiajia Chen, Dr. | Contact | 13810773718 | chenjiaj2009@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bingyan Cao, Dr. | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology, Genetics, Metabolism | Recruiting | Beijing | Beijing Municipality | 010 | China |
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| ID | Term |
|---|---|
| D006130 | Growth Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C562190 | polyethylene glycol-recombinant human growth hormone |
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