[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-short-stature\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-short-stature":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,63,85,109,141,164,191,214],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100609997","phase-3-trial-investigating-the-efficacy-and-safety-of-weekly-lonapegsomatropin-compared-to-daily-somatropin-in-children-and-adolescents-with-short-stature-or-growth-failure-due-to-growth-hormone-sufficient-disorders-100609997",false,"NCT07221851","Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders","A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature","Inclusion Criteria:\n\n1. Chronological age between ≥2 and \\\u003C18 years, at start of screening.\n2. Naïve to growth hormone and growth hormone promoting therapies.\n3. Prepubertal.\n4. Able to stand without assistance.\n5. Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:\n\n   TS or SHOX-D (Léri-Weill dyschondrosteosis):\n   1. Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.\n   2. Impaired growth or short stature defined as:\n\n   (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States\n\n   SGA without catch-up growth:\n\n   c. Birth weight and\u002For birth length \\\u003C -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used.\n\n   d. Impaired growth or short stature defined as: (i.) AHV \\\u003C25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\\u003C -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height \\\u003C -2.5 SDS for age and sex according to the for children ≥ 2 years and \\\u003C 3 years\n\n   ISS:\n\n   e. Height \\\u003C -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature.\n\n   f. Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS \\>0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.\n6. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.\n7. Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB\u002FHREC\u002FIEC.\n\nExclusion Criteria:\n\n1. Advanced bone age X-ray by central reading defined as \\>20% above chronological age in months (Greulich 1959).\n2. Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.\n3. Current clinical diagnosis of diabetic retinopathy\n4. Any diagnosis or presence at screening of the following:\n\n   1. Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.\n   2. Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.\n5. Signs\u002Fsymptoms of intracranial hypertension, active proliferative retinopathy.\n6. Uncontrolled hypo- or hyperthyroidism.\n7. Uncontrolled diabetes mellitus (defined as: HbA1c \\>7.5% from central laboratory at screening).\n8. Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and\u002For cardio-thoracic surgery due to their independent effects on growth.\n9. Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2).\n10. Undiagnosed or uncontrolled hypertension.\n11. Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit\u002Fhyperactivity disorder (ADHD).\n12. High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.\n13. Female who is pregnant, plans to be pregnant, or breastfeeding.\n14. Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.\n15. Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.\n16. Exclusion Criteria only applicable to TS:\n\n    1. Presence of Y chromosome material on genetic testing without history of gonadectomy.\n    2. Less than 10% of 45,X mosaicism.\n    3. Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.\n17. Exclusion Criteria only applicable to SGA:\n\n    a. Any known clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements: (i.)Chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors.\n\n    (ii.)Congenital abnormalities (causing skeletal abnormalities), including but not limited to skeletal dysplasias.\n18. Exclusion Criteria only applicable to ISS:\n\n    1. Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.","ALL","2 Years","17 Years",{"count":20,"type":21},186,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\\u003C18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.",[27,28,29,30],"Turner Syndrome","Short Stature Homeobox Gene Mutation","Idiopathic Short Stature","Small for Gestational Age at Delivery",[27,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,28,49,29],"Noonan Syndrome","Growth Hormone","Short Stature","Growth Failure","Sex Chromosome Disorders","Chromosome Disorders","Endocrine System Diseases","Pituitary Hormones, Anterior","Pituitary Hormones","Hormones","Hormone Substitutes","Human Growth Hormone","Lonapegsomatropin","Sex Chromosome Disorders of Sex Development","Impaired Growth","somatropin","Growth Hormone Sufficiency","Short Stature Children Born Small for Gestational Age","RECRUITING","2026-06-19",{"date":53,"type":54},"2026-06-23","ACTUAL",{"date":56,"type":54},"2025-12-12",{"date":58,"type":21},"2029-03",{"name":60,"class":61},"Ascendis Pharma A\u002FS","INDUSTRY",25,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100539910","a-study-to-assess-growth-in-children-with-idiopathic-short-stature-100539910","NCT06309979","A Study to Assess Growth in Children With Idiopathic Short Stature","A Multicenter, Observational Study to Characterize Growth in Children With Idiopathic Short Stature","Inclusion Criteria:\n\n1. Participants must be \\> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.\n2. A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https:\u002F\u002Fwww.cdc.gov\u002Fgrowthcharts\u002Fzscore.htm).\n3. Participants who have either never received hGH, or who are currently receiving hGH treatment.\n4. Historic stimulation test result with serum or plasma GH level greater than 10 μg\u002FL.\n5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.\n2. Known presence of one or more pituitary hormone deficiencies\n3. Bone age advanced over chronological age by more than 3 years.\n4. For hGH naïve participants, historic stimulation test result with serum or plasma GH level greater than 10 μg\u002FL or serum IGF-1 in the normal range for age (between -1.00 SDs and +2.00 SDs).\n5. For participants currently on hGH treatment, historic results before GH treatment of stimulation test with serum or plasma GH level greater than 10 μg\u002FL or serum IGF-1 test between -1.00 SDs and +2.00 SDs.\n6. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .","16 Years",{"count":72,"type":21},300,"OBSERVATIONAL","Study 111-903 will generate baseline growth data in children with ISS by collecting growth measurements and other variables of interest.",[29],"2026-06-18",{"date":53,"type":54},{"date":79,"type":54},"2024-08-08",{"date":81,"type":21},"2040-12-31",{"name":83,"class":61},"BioMarin Pharmaceutical",38,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100545457","phase-2-a-phase-2-study-of-vosoritide-in-children-with-idiopathic-short-stature-100545457","NCT06382155","A Phase 2 Study of Vosoritide in Children With Idiopathic Short Stature","A Phase 2, Randomized, Controlled, Multicenter Study of Vosoritide in Children With Idiopathic Short Stature","Key Inclusion Criteria:\n\n1. Height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth charts\n2. If participant is ≥ 5 years at Screening,must be Tanner Stage I to be eligible for enrollment and randomization3. Historic stimulation test result with serum or plasma GH level greater than 10 μg\u002FL or serum IGF-1 in the normal range for age (≥ -1.00 SDs and ≤+2.00 SDs).\n\nKey Exclusions:\n\n1. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome), ACAN deficiency.\n2. Previous treatment with a growth promoting agent","3 Years","11 Years",{"count":95,"type":21},100,[97],"PHASE2","The purpose of this study is to evaluate i) the effect of multiple doses of vosoritide and ii) the effect of the therapeutic dose of vosoritide compared to human growth hormone (hGH)(hGH; only in the United States), in children with idiopathic short stature (ISS).",[29],"2026-05-20",{"date":102,"type":54},"2026-05-22",{"date":104,"type":54},"2024-10-21",{"date":106,"type":21},"2036-12",{"name":83,"class":61},47,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":137,"locationsCount":140},"100505227","multidisciplinary-evaluation-and-a-genome-wide-analysis-in-a-cohort-of-idiopathic-short-stature-patients-100505227","NCT05858606","Multidisciplinary Evaluation and a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients","Pilot Study of Ethiology Research by a Multidisciplinary Evaluation Then a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients","PAG PETI","Inclusion Criteria:\n\n* Children aged 4 to 18 years\n* 2 sexes\n* Height less than -2.5DS (standard deviations of the AFPA- CRESS\u002FInserm -CompuGroup Medical 2018 curve) or less than -2DS of the TCP (parental target height, corresponding to the average of parental heights +6.5 cm in boys, -6.5 cm in girls)\n* Normal karyotype + FISH SHOX for girls\n* Previously performed:celiac disease antibodies, WBC-platelets, CRP, blood ionogram, creatinine, blood calcium, blood phosphorus, ASAT, ALAT, PAL, PTH, TSH, T4L, growth hormone test normal according to the standards of the laboratory of the CHU of Montpellier\n* Acceptance of X-rays, in addition to those already performed as part of the care, which will not be repeated if necessary: spine front and profile, pelvis front, 1 upper limb front, 1 lower limb front F, hands and feet front\n* Acceptance of photographs: whole body with underwear, face face and profile, 2 faces of hands; feet, face\n* Acceptance of blood samples for the child and the 2 parents (trio)\n* Consent signed by both parents\n\nExclusion Criteria:\n\n* Intellectual disability (IQ below 70)\n* Cardiac, renal, digestive or cerebral malformation, cleft lip or palate, hearing or visual impairment, epilepsy\n* Renal or cardiac insufficiency, digestive or chronic inflammatory pathology\n* Previously established genetic diagnosis","4 Years","18 Years",{"count":120,"type":21},200,[122],"NA","This trial aims to evaluate the prevalence of idiopathic short stature among children whose growth is above -2,5SD (AFPA- CRESS\u002FInserm -CompuGroup Medical 2018 curve) or above -2SD of the parental target size (taking child gender into account), after exclusion of classical pediatric and endocrinologic pathologies, and to evaluate the prevalence of monogenic causes of idiopathic short stature. A two-step study will be performed. The first one consists in a standardized multidisciplinary clinico-radiological evaluation of those children to evaluate the real prevalence of idiopathic short stature (ISS) among these patients. The second step consists in performing a whole genome sequencing analysis in the 30 first patients for whom the diagnosis of ISS is confirmed.",[29],[126,127,128,129,130],"idiopathic short stature","whole genome analysis","monogenic conditions","syndromic disorders","skeletal dysplasia","2026-04-29",{"date":133,"type":54},"2026-05-06",{"date":135,"type":54},"2026-03-16",{"date":58,"type":21},{"name":138,"class":139},"University Hospital, Montpellier","OTHER",1,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":93,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":152,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":84},"100587355","phase-3-the-efficacy-and-safety-of-inpegsomatropin-injection-in-children-with-idiopathic-short-stature-100587355","NCT06927310","The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature","A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Inpegsomatropin Injection, s.c Once a Week, Compared With Recombinant Human Growth Hormone (rhGH) Injection in Children With Idiopathic Short Stature (ISS).","Inclusion Criteria:\n\n* Prepubertal children: boys aged ≥3 years and \\\u003C11 years at screening with testicular volume \\\u003C4 mL; girls aged ≥3 years and \\\u003C10 years at screening with breast development at Tanner Stage I, i.e., no palpable breast glandular tissue.\n* Compared to chronological age, bone age is advanced by no more than 1 year or delayed by no more than 2 years (i.e., -2 years ≤ bone age - chronological age ≤ 1 year).\n* Height at screening is below -2 standard deviations (SD) from the mean for age and sex, with height reference to Appendix 1.\n* Body mass index (BMI) is within the 5th to 95th percentile for age and sex of healthy children, with reference to Appendix 2.\n* Peak GH level ≥10.0 ng\u002Fml in at least one GH stimulation test.\n* No prior systemic pharmacological treatment for growth promotion (continuous use ≥1 month), including but not limited to growth hormone, insulin-like growth factor 1 (IGF-1), etc.\n* The legal guardian understands and signs the informed consent form. If the participants is ≥8 years old, they must also sign the informed consent form. For participants under 8 years old who are able to express their consent, their assent should be clearly documented.\n\nExclusion Criteria:\n\n* Individuals with closed epiphyses;\n* Other types of growth and developmental abnormalities, including confirmed or highly suspected growth hormone deficiency (GHD), Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, Turner syndrome, small for gestational age, short stature due to SHOX gene abnormalities, growth delay due to malnutrition, growth delay due to hypothyroidism, and other short statures with a clear etiology; genetic testing results must be obtained before randomization to exclude short stature caused by definite genetic abnormalities;\n* Individuals who have participated in any other clinical trial within 3 months prior to screening and have received pharmacological or non-pharmacological interventions;\n* Individuals who received inhaled corticosteroids for more than 2 consecutive weeks, or oral or intravenous corticosteroids for more than 1 consecutive week, within the 3 months prior to screening;\n* Individuals who are currently receiving or require long-term treatment with other therapies that may affect growth, including but not limited to methylphenidate, sex hormones, gonadotropin-releasing hormone analogs, aromatase inhibitors, anabolic agents, insulin, etc.;\n* Individuals with abnormal liver or kidney function at screening (ALT \\> 1.5 times the upper limit of normal, Cr \\> upper limit of normal);\n* Individuals diagnosed with diabetes mellitus, or with fasting blood glucose ≥6.1 mmol\u002FL on two consecutive occasions;\n* Individuals with chronic infectious diseases, such as chronic hepatitis B;\n* Individuals with systemic chronic diseases, such as moderate to severe anemia, malnutrition, hypothyroidism, chronic kidney disease, cardiovascular diseases (e.g., dilated cardiomyopathy, etc.), psychiatric and psychological disorders, or those with congenital anomalies requiring clinical intervention as determined by the investigator;\n* Individuals with congenital skeletal abnormalities, or those with scoliosis exceeding 15°, limping, or a history of slipped capital femoral epiphysis;\n* Individuals with a history of increased intracranial pressure;\n* Individuals with a history of malignancy or currently having active malignancy, including intracranial tumors;\n* Individuals with severe allergic constitutions, or known allergies to growth hormone or its excipients;\n* Individuals with any other disease that the investigator deems may endanger the subject's safety or compromise compliance with the study protocol.",{"count":72,"type":21},[24],"This is a multicenter, randomized, open-label, active-controlled Phase III clinical trial to evaluate the efficacy and safety of Inpegsomatropin injection，once a week，compared with recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). It plans to enroll 300 children with ISS, who will be randomized , stratified by gender and age, and assigned to either the experimental group or the positive controlled group. Each participant will undergo a screening period (up to 12 weeks), a treatment period (52 weeks), and a post-treatment follow-up period (5 weeks). And the safety and efficacy will be evaluated.",[29],[153,154],"Inpegsomatropin Injection","Recombinant Human Growth Hormone Injection","2026-03-10",{"date":157,"type":54},"2026-03-11",{"date":159,"type":54},"2025-04-28",{"date":161,"type":21},"2028-06",{"name":163,"class":61},"Xiamen Amoytop Biotech Co., Ltd.",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":171,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":140},"100627547","phase-1-a-study-phase-1b2-of-gensci134-in-children-with-idiopathic-short-stature-iss-100627547","NCT07450053","A Study (Phase 1b\u002F2) of GenSci134 in Children With Idiopathic Short Stature (ISS)","A Phase Ib\u002FII Multicenter, Randomized, Open-label, Active-controlled, Single\u002FMultiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Idiopathic Short Stature","Inclusion Criteria:\n\n* sInformed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.\n* At the time of signing the Informed consent form (ICF), the following conditions must be met:\n* Phase Ib:\n\nGirls: age ≥3 and ≤11 years, breast development at Tanner stage 1, body weight ≥16 kg; Boys: age ≥3 and ≤12 years, testis volume \\\u003C4 mL, body weight ≥16 kg.\n\n● Phase II: Girls: age ≥3 and ≤9 years, breast development at Tanner stage 1; Boys: age ≥3 and ≤10 years, testis volume \\\u003C4 mL.\n\n* Diagnosis of ISS at the time of ICF signing .\n* BMI within the range of ±2 SD of the mean BMI for age and sex at screening（Phase II only）.\n* No prior exposure to GH or IGF-1 therapy.\n* Historical measurements of body height within 6-18 months prior to screening are available(Phase II only).\n* BA-CA ≤ 1 year at screening(Phase II only).\n\nExclusion Criteria:\n\n* Presence of any suspected or confirmed condition known to affect growth, including but not limited to:\n\n  1. GHD.\n  2. Turner Syndrome.\n  3. Noonan syndrome.\n  4. Laron Syndrome.\n  5. Other genetic syndromes with short stature that are caused by chromosomal abnormalities or gene mutations, including but not limited to Prader-Willi syndrome, abnormal SHOX-1 gene analysis, or GH receptor deficiency.\n  6. Born small for gestational age:\n  7. Growth retardation due to malnutrition.\n  8. Growth retardation due to hypothyroidism.\n  9. Short stature with any other clearly identified etiology.\n* Epiphyseal closure (Phase II only).\n* Abnormal liver function, renal function, or coagulation profile.\n* Current or prior history of any malignant disease; or a family history of malignancy.\n* Presence of impaired glucose metabolism, or HbA1c ≥ 5.7%, or a confirmed diagnosis of diabetes mellitus.\n* Clear medical history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, hematological, neurological, or metabolic disorders, or any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.\n* Any clinically significant abnormality in vital signs, physical examinations, laboratory tests, 12-lead ECG, full spine anteroposterior and lateral X-ray, or B-mode ultrasound, other than those associated with the study disease, as judged by the investigator and will make the participant unsuitable for the study.\n* A positive result for any of the following serological tests during the screening period: HBsAg, Anti-HCV, Anti-HIV, or TP-Ab.\n* Known highly allergic diathesis or hypersensitivity to growth hormone products or any excipient of the investigational drug.\n* Use within a specified period prior to screening or planned use during the study of medications that may interfere with growth hormone secretion or action, or other drugs known to affect growth and development.\n* Participation in another clinical trial within 3 months prior to screening, or if the time since the last dose is less than 5 half-lives of the previous investigational drug at screening.\n* Children have been treated with systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening (Phase II only).\n* Children have been treated with inhaled budesonide or equivalent doses of inhaled glucocorticoids for more than 4 consecutive weeks within the last 12 months prior to screening (Phase II only).\n* Receipt of any blood products within 3 months prior to the first dose, poor peripheral venous access, or any medical condition that will preclude tolerance of the blood sampling procedures.\n* Administration of any vaccine within 14 days prior to the first dose or planned vaccination at any time during the study period.\n* The participant and\u002For the parent\u002Flegal representative is likely to be non-compliant with respect to study conduct, as judged by the investigator.\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.","12 Years",{"count":173,"type":21},128,[175,97],"PHASE1","This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation study to evaluate the safety, tolerability, PK\u002FPD profile, and immunogenicity of a single subcutaneous dose of GenSci134 in children with idiopathic short stature (ISS).\n\nPhase II is a multicenter, randomized, open-label, active-controlled, multiple-dose, parallel-group study to assess the efficacy and safety of multiple subcutaneous doses of GenSci134 at different levels versus Norditropin® in children with ISS. It will also evaluate PK\u002FPD profile, immunogenicity, and biomarkers to support dose selection for Phase III.",[29],[179,180],"ISS","GenSci134","NOT_YET_RECRUITING","2026-02-27",{"date":184,"type":54},"2026-03-04",{"date":186,"type":21},"2026-03-06",{"date":188,"type":21},"2028-12-31",{"name":190,"class":61},"Changchun GeneScience Pharmaceutical Co., Ltd.",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":200,"studyType":73,"phases":4,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":140},"100423808","long-term-safety-and-effectiveness-of-growtropin-ii-treatment-in-children-with-short-stature-100423808","NCT04798690","Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature","Open, Multi-center, Non-interventional, Prospective\u002F Retrospective Observational Study on Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature","Inclusion Criteria:\n\n* Children with short stature by growth hormone deficiency(GHD) or idiopathic short stature (ISS) or turner's syndrome(TS) or small for gestational age(SGA)\n* Children who has official height record at least 6 months prior\n\nExclusion Criteria:\n\n* Children with Epiphyseal closure",{"count":199,"type":21},2500,"10 Years","This study evaluates long-term safety and effectiveness of Growtropin®-II treatment in children with short stature.",[203,29,27,204],"Growth Hormone Deficiency","Small for Gestational Age","2023-04-11",{"date":207,"type":54},"2023-04-12",{"date":209,"type":54},"2021-02-08",{"date":211,"type":21},"2031-12",{"name":213,"class":61},"Dong-A ST Co., Ltd.",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":73,"phases":4,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":140},"100178992","long-term-safety-and-effectiveness-of-growth-hormone-with-ghd-ts-crf-sga--iss-and-pws-in-children-100178992","NCT01604395","Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children","An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. \u002F Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA, ISS and PWS in Children","LGS","Inclusion Criteria:\n\n* short stature children aged 2 years or more\n* children with GHD,TS, CRF, SGA or ISS\n* written informed consent from the person, person's parent or legal guardian",{"count":223,"type":21},6000,"The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj.\u002FEutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).",[203,27,226,204,29],"Chronic Renal Failure",[228,229,230,231,179,232],"GHD","TS","CRF","SGA","PWS","2021-02-17",{"date":235,"type":54},"2021-02-21",{"date":237,"type":4},"2012-01",{"date":239,"type":21},"2032-12-31",{"name":241,"class":61},"LG Chem"]