[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657678":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":32,"overallOfficials":11,"centralContacts":42,"locations":52,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":11,"enrollmentInfo":77,"targetDuration":11,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":11,"overallStatus":86,"whyStopped":11,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Annualized Height Velocity (AHV)",null,"Week 52",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20,26],{"label":21,"type":22,"description":23,"interventionNames":24},"PEG-hGH Injection 0.3 mg\u002Fkg\u002Fweek","EXPERIMENTAL","Subjects receive PEG-hGH injection at a dose of 0.3 mg\u002Fkg\u002Fweek by subcutaneous injection, once weekly, for 52 weeks during the treatment period. In the extension period, all subjects continue to receive PEG-hGH injection 0.3 mg\u002Fkg\u002Fweek for another 52 weeks.",[25],"Drug: PEG-hGH Injection",{"label":27,"type":28,"description":29,"interventionNames":30},"hGH Injection 0.066 mg\u002Fkg\u002Fday","ACTIVE_COMPARATOR","Subjects receive hGH injection at a dose of 0.066 mg\u002Fkg\u002Fday by subcutaneous injection, once daily, for 52 weeks during the treatment period. In the extension period, subjects switch to PEG-hGH injection 0.3 mg\u002Fkg\u002Fweek for 52 weeks.",[31],"Drug: hGH Injection",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":11},"DRUG","PEG-hGH Injection","PEGylated recombinant human growth hormone (PEG-hGH) injection, trade name Jinsizeng. Dose: 0.3 mg\u002Fkg\u002Fweek, subcutaneous injection, once weekly. Specification: 54 IU\u002F9.0 mg\u002F1.0 mL\u002Fvial. Administered via electronic pen injector.",[21],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"hGH Injection","Recombinant human growth hormone (hGH) injection, trade name Saizeng. Dose: 0.066 mg\u002Fkg\u002Fday, subcutaneous injection, once daily. Specification: 30 IU\u002F10 mg\u002F3 mL\u002Fvial. Administered via electronic pen injector.",[27],[43,48],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Xiaoping Luo","CONTACT","+8613387522645","xpluo888@sina.com",{"name":49,"role":45,"phone":50,"phoneExt":11,"email":51},"Ling Hou","+8613437131846","houlingtj@163.com",[53],{"facility":54,"status":11,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":11},"Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology.","Wuhan","Hubei","430030","China","CN",{"type":61,"coordinates":62},"Point",[63,64],114.26667,30.58333,{"lat":64,"lon":63},{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100657678","phase-3-a-phase-iii-clinical-study-of-jinpei-growth-hormone-injection-in-the-treatment-of-short-stature-children-with-small-for-gestational-age-sga-100657678",false,"NCT07841678","A Phase III Clinical Study of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)","A Multicenter, Randomized, Open-Label, Active-Controlled Phase III Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Jinpei Growth Hormone Injection in the Treatment of Short Stature Children With Small for Gestational Age (SGA)","Inclusion Criteria:\n\n* Clinical diagnosis of small for gestational age (SGA), with birth certificate or discharge record; gestational age ≥28 weeks; birth weight and\u002For length below the 10th percentile (P10) for sex and gestational age.\n* Age ≥3 years at the time of informed consent (calculated from birth date on birth certificate\u002FID).\n* Prepubertal boys and girls (Tanner stage I).\n* Screening height \\\u003C -2 SD of normal height reference values for same sex and chronological age.\n* Screening bone age \\\u003C chronological age + 1 year (bone age X-ray within 6 months before screening acceptable).\n* No prior treatment with growth hormone, IGF-1, or insulin-like secretagogues.\n* Subject and guardian able to voluntarily sign informed consent form (ICF) and comply with study procedures; for subjects without civil capacity, guardian's written informed consent required, with subject assent when possible.\n\nExclusion Criteria:\n\n* Hypersensitivity to growth hormone class drugs or their excipients.\n* Suspected or confirmed pediatric growth hormone deficiency (GHD) requiring GH stimulation testing (GH peak \\>7 ng\u002FmL excludes GHD).\n* Known chromosomal or gene mutations affecting growth, or known syndromes including but not limited to GHD, Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Silver-Russell syndrome, skeletal dysplasia, SHOX gene abnormalities.\n* Any known or suspected disease\u002Fcondition that may cause short stature and may interfere with endpoint evaluation, including but not limited to chronic kidney disease, diabetes, skeletal dysplasia (with family history), severe spinal abnormalities, malnutrition, hypothyroidism, immunodeficiency.\n* Current signs\u002Fsymptoms of increased intracranial pressure, active proliferative retinopathy, or history of slipped capital femoral epiphysis or intracranial hypertension.\n* Cognitive impairment, neurodevelopmental disorder or psychiatric illness that may interfere with endpoint evaluation.\n* Current intracranial tumor, hematologic malignancy or other malignant tumor (regardless of treatment); family history of tumor or high tumor risk (e.g., Bloom syndrome, Fanconi syndrome, Down syndrome).\n* Positive HBsAg at screening; history or diagnosis of hepatitis C, HIV infection or tuberculosis.\n* Abnormal screening laboratory values considered by investigator to interfere with safety evaluation (ALT \\>1.5×ULN; creatinine \\>1.5×ULN).\n* Screening indicates impaired fasting glucose, impaired glucose tolerance or diabetes.\n* Systemic corticosteroid treatment within 3 months before screening (\\>28 days cumulative or \\>14 days continuous).\n* Prior use of aromatase inhibitors, GnRH analogs, sex hormones, protein anabolic drugs, or other drugs affecting growth and development.\n* Unable to receive subcutaneous injections (e.g., anticoagulant therapy, bleeding disorders, idiopathic thrombocytopenic purpura).\n* Claustrophobia or inability to undergo head MRI.\n* Participation in other clinical trials within 3 months before screening.\n* Other conditions considered by investigator unsuitable for enrollmen.","ALL","3 Years",{"count":78,"type":79},105,"ESTIMATED","INTERVENTIONAL",[82],"PHASE3","This is a multicenter, randomized, open-label, active-controlled Phase III clinical study to evaluate the efficacy, safety and pharmacokinetic (PK) characteristics of once-weekly PEG-hGH injection compared with once-daily hGH injection in the treatment of prepubertal children with short stature due to small for gestational age (SGA) who have not received prior growth hormone treatment.\n\nEligible subjects will be randomized in a 2:1 ratio to receive either PEG-hGH injection 0.3 mg\u002Fkg\u002Fweek (experimental group) or hGH injection 0.066 mg\u002Fkg\u002Fday (active comparator group) for 52 weeks, followed by a 52-week extension period in which all subjects receive PEG-hGH injection 0.3 mg\u002Fkg\u002Fweek. The primary endpoint is annualized height velocity (AHV) at Week 52.",[85],"Small for Gestational Age","NOT_YET_RECRUITING","2026-09-20",{"date":89,"type":90},"2026-09-25","ACTUAL",{"date":92,"type":79},"2026-09",{"date":94,"type":79},"2030-01",{"name":5,"class":6},1]