[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"growth-hormone-treatment\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:growth-hormone-treatment":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100518971","the-efficacy-and-safety-of-pegylated-gh-for-the-treatment-of-short-stature-in-chinese-children-globe-reg-100518971",false,"NCT06037473","The Efficacy and Safety of PEGylated GH for the Treatment of Short Stature in Chinese Children-GLOBE Reg","A Real-world Study of the Efficacy and Safety of PEGylated Recombinant Human Growth Hormone Injection in the Treatment of Short Stature in Chinese Children From the Global Registry for Novel Therapies For Rare Bone or Endocrine Conditions","Inclusion Criteria:\n\nPatients with endogenous growth hormone deficiency, Turner Syndrome, SGA, idiopathic short stature, etc. treated with polyethylene glycol recombinant human growth hormone injection\n\nExclusion Criteria:\n\nPatients with serious heart and lung, blood system, malignant tumors and other diseases or systemic infections, immune function is low and Persons with mental illness;","ALL","18 Years",{"count":19,"type":20},2600,"ESTIMATED","OBSERVATIONAL","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.",[24,25],"Growth Hormone Treatment","Growth Disorders","RECRUITING","2025-08-28",{"date":29,"type":30},"2025-09-04","ACTUAL",{"date":32,"type":30},"2023-08-01",{"date":34,"type":20},"2029-08-01",{"name":36,"class":37},"Beijing Children's Hospital","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":38},"100550524","phase-4-effects-of-growth-hormone-therapy-on-metabolic-function-in-fatty-liver-post-pituitary-adenoma-surgery-100550524","NCT06448195","Effects of Growth Hormone Therapy on Metabolic Function in Fatty Liver Post-Pituitary Adenoma Surgery","Growth Hormone Replacement Therapy on Metabolic Effects in Patients With Fatty Liver Caused by Growth Hormone Deficiency After Pituitary GH Adenoma Surgery: A Monocentric, Prospective, Randomized, Parallel-controlled Clinical Study.","Inclusion Criteria:\n\n* Have fully understood the informed consent and signed the informed consent;\n* Age: 18-60 years old;\n* Patients diagnosed with adult growth hormone deficiency (AGHD) (GH stimulation test: GH peak ≤5ug\u002Fl or organic hypothalamic-pituitary disease ≥3 pituitary hormone deficiency with IGF-1 \\\u003C -2SD)\n* Patients with pituitary growth hormone adenoma proved pathologically after surgery\n* Anterior pituitary hormone supplementation (except growth hormone)\n* The liver fat content was more than 11% after six months to two years of operation by proton magnetic resonance spectroscopy (1H MRS).\n* Those who have not taken lipid-regulating drugs (statins, Bates);\n* Blood pressure \\\u003C150\u002F95mmHg, did not take any antihypertensive drugs;\n\nExclusion Criteria:\n\n* Have any of the following liver disease history: chronic hepatitis, cirrhosis, liver cancer, autoimmune liver disease, alcoholic liver disease, hereditary liver disease\n* Significant abnormal liver function: ALT or AST≥ 2 times the upper limit of normal; HBsAg (+), and\u002For HCV-Ab (+);\n* Patients with serum creatinine value ≥1.5mg\u002FdL (133umol\u002FL);\n* Patients with severe heart disease (patients with a history of myocardial infarction and heart failure and\u002For severe arrhythmia);\n* Patients with severe infection, other operations within 6 months, or severe trauma;\n* Alcohol consumption (alcohol): male ≥140g\u002Fweek; Female ≥70g\u002Fweek;\n* Poorly controlled diabetic patients: HbA1c \\>9.5% within three months; Or use hypoglycemic drugs that may affect liver histopathology, including pioglitazone, GLP-1, and DP-4 inhibitors;\n* Patients with allergy or intolerance to the same drug used in the trial;\n* In the next 1 year, there are pregnancy plans or breastfeeding patients or patients with mental disorders;\n* Patients who have participated in other clinical trials within 24 weeks.","60 Years",{"count":48,"type":20},40,"INTERVENTIONAL",[51],"PHASE4","Growth Hormone (GH) is essential for maintaining fat, muscle, bone, and energy balance. Adult Growth Hormone Deficiency (GHD) affects about 0.3% of adults. GHD, common post-pituitary tumor surgery or radiotherapy, disrupts lipid metabolism, increasing triglycerides and low-density lipoprotein cholesterol while decreasing high-density lipoprotein cholesterol. This is especially severe in GH adenoma patients, whose lipid metabolism issues worsen post-surgery, increasing the risk of atherosclerosis. Fat accumulates in the liver first, making liver fat content a key early indicator of metabolic disorders, which can lead to diabetes and atherosclerosis. Early intervention is crucial as liver fat deposition in Nonalcoholic Fatty Liver Disease (NAFLD) is reversible.\n\nRecombinant human growth hormone can treat GHD-related lipid metabolism disorders, but research on its effects on liver fat in post-surgery GH adenoma patients is limited. The investigators plan to treat these patients with 1 mg\u002Fweek of recombinant human growth hormone for 24 weeks, aiming to normalize insulin-like growth factor-1 levels. Liver fat content changes will be measured using proton magnetic resonance spectroscopy (1H MRS) and Fibroscan. Changes in weight, BMI, waist circumference, fasting blood glucose, blood lipids, and other metabolic factors will also be evaluated to assess treatment efficacy and safety.\n\nZhongshan Hospital, affiliated with Fudan University, performs over 300 pituitary tumor surgeries annually, including 100 GH adenoma cases. The hospital has extensive experience and can enroll 40 patients. The Endocrinology Department excels in evaluating lipid metabolism disorders in NAFLD using non-invasive methods. As a major hospital in Shanghai, it has ample patients to meet study requirements. Detailed exit criteria and rescue plans have been established to address potential adverse events during the study.",[24],"2024-06-07",{"date":56,"type":30},"2024-06-10",{"date":58,"type":30},"2023-01-01",{"date":60,"type":20},"2025-12-31",{"name":62,"class":37},"Shanghai Zhongshan Hospital",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":49,"phases":73,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":38},"100450326","phase-4-a-real-world-study-of-the-effect-of-early-peg-rhgh-therapy-on-cognitive-development-of-sga-infants-100450326","NCT05144035","A Real World Study of the Effect of Early PEG-rhGH Therapy on Cognitive Development of SGA Infants","Inclusion Criteria:\n\n1. Provide informed consent signed and dated by the subject's legal guardian;\n2. The subjects met the clinical diagnosis of small for gestational age infants.\n3. The age ranged from 6 months to 2 years old (including 6 months and 2 years old);\n4. Height and head circumference are lower than the reference value - 2sd (including-2sd), whose weight is lower than the 10th percentile of the reference value of normal children of the same age and sex;\n5. The total developmental quotient GQ calculated according to Griffiths mental development scale is less than 100 points (100 points) Indicates that the developmental age is consistent with the physiological age);\n6. Birth gestational age ≥ 37 weeks and \\\u003C 42 weeks, single birth and non test tube baby;\n7. Symmetrical SGA: birth weight index \\> 2.0 (gestational age = 37 weeks), or \\> 2.2 (gestational age \\> 37 weeks) . Weight index \\[birth weight (g) × 100 \u002F birth length (CM) \\];\n8. Normal thyroid function or normal after replacement therapy;\n9. No previous rhGH treatment\n\nExclusion Criteria:\n\n1. Patients with abnormal liver and kidney function (ALT \\> 2 times the upper limit of normal value, Cr \\> the upper limit of normal value);\n2. Severe familial dwarfism (father height \\\u003C 155cm or mother height \\\u003C 145cm);\n3. Definite neurological defects and \u002F or severe neurodevelopmental retardation (the total development quotient calculated according to Griffiths mental development scale is less than 70), definite syndrome affecting cognitive development; Severe perinatal complications (such as severe asphyxia, sepsis, necrotizing enterocolitis, respiratory distress syndrome with long-term sequelae);\n4. Genetic metabolic diseases (such as congenital hypothyroidism, phenylketonuria, methylmalonic acidemia);\n5. Congenital skeletal dysplasia, or moderate or above scoliosis (or scoliosis ≥ 15 °) requiring treatment or claudication;\n6. Short stature with other definite causes, such as osteochondral dysplasia and Turner syndrome (TS), Noonan syndrome (NS), Prader Willi syndrome (PWS), Angelman syndrome (as), silver Russell syndrome (SRS), or other genetically confirmed syndromes (Note: diseases that meet the clinical diagnostic criteria adopt the method of clinical diagnosis; when the clinical diagnosis is difficult to be clear, or the diagnosis of the disease depends on gene screening, the method of gene diagnosis shall be supplemented \u002F adopted);\n7. patients with diabetes or fasting blood glucose are abnormal and the researchers believe that they may affect the safety of subjects.\n8. Continuous application of other hormone therapy or systemic glucocorticoid therapy for more than one month in the past 6 months (local or inhaled glucocorticoids are allowed);\n9. Patients with a history of convulsions or epilepsy, except for the relief or recovery of convulsions or epilepsy symptoms after the release of definite causes (such as high fever, calcium deficiency, brain infection, etc.);\n10. Patients with other systemic chronic diseases;\n11. Patients with confirmed tumors, or patients with family history of tumors (two or more tumor patients within three generations of immediate relatives), previous tumor history or considered as patients with high risk of tumors in combination with other information, clear syndromes with high risk of tumors (such as Bloom syndrome, Fanconi syndrome, Down syndrome, etc.);\n12. Known high allergic constitution or allergic to the test drug in this study;\n13. Those who have participated in clinical trials of other drugs within 3 months (the placebo group is not subject to this restriction);\n14. Have received drug treatment that may interfere with GH secretion or GH effect within 3 months (including but not limited to any type of recombinant human growth hormone and protein assimilation drugs (including but not limited to oxandron, danazol and stanazol) other than rhGH injection);\n15. The investigator considers that it is not suitable to be selected for this clinical trial.","6 Months","2 Years",{"count":72,"type":20},138,[51],"Cognitive impairment is independently related to low birth weight, low birth length and small head circumference. SGA children who have not experienced height and \u002F or head circumference catch-up have the worst cognitive function. The serum IGF-1 level of short SGA children is significantly lower than that of catch-up SGA children. This may be due to the defect of GH-IGF-1 axis, resulting in some hGH \u002F IGF-1 deficiency.\n\nGH treatment can induce catch-up growth of head circumference, especially for those with small birth head circumference, growth hormone can help to improve IQ, behavior and self cognition of children with SGA.\n\nTwo years after birth is the most critical period for children's physical, neurological, cognitive and emotional development. This study evaluated the effect of growth hormone treatment on the improvement of cognitive function and growth and development of symmetrical SGA children who did not show catch-up growth from 6 months to 2 years old.\n\nThis is an innovative study. The minimum age of previous similar studies is 19 months. The starting age of this study is 6 months, and the results are to improve the cognitive development of SGA infants. This is the first of its kind. Although the safety of growth hormone in SGA infants younger than 2 years old has not been reported, it is based on a number of studies on the application of growth hormone in infants, such as PWS and GHD, It can be expected that there will be no short-term and long-term adverse reactions.\n\nThe study was conducted in 17 hospitals led by Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of science and technology",[76,24,77],"Small for Gestational Age Infant","Cognitive Developmental Disorder",[79,80,81],"SGA","PEG-rhGH","Cognitive developmental","2023-04-17",{"date":84,"type":30},"2023-04-19",{"date":86,"type":30},"2022-04-06",{"date":88,"type":20},"2026-06-30",{"name":90,"class":37},"Tongji Hospital"]