[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-growth-hormone-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-growth-hormone-deficiency":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100627543","phase-1-a-study-of-gensci134-in-children-with-growth-hormone-deficiency-pghd-100627543",false,"NCT07450001","A Study of GenSci134 in Children With Growth Hormone Deficiency (PGHD)","A Phase Ib\u002FII Multicenter, Randomized, Open-label, Active-controlled, Single\u002FMultiple-dose, Dose-finding, Clinical Study of GenSci134 in Children With Growth Hormone Deficiency","Inclusion Criteria:\n\n1. Informed consent of parent or legal representative of participant and child assent, as age appropriate must be obtained before any study-related activities.\n2. At the time of signing the Informed consent form (ICF), the following conditions must be met:\n\n   Phase Ib:\n\n   Girls: age ≥3and ≤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:\n\n   Girls: age ≥3 and ≤9 years, breast development at Tanner stage 1; Boys: age ≥3 and ≤10 years, testis volume \\\u003C4 mL.\n3. BMI within the range of ±2 SD of the mean BMI for age and sex at screening\n4. Height is at least 2 SD below the mean HT for age and sex (HT SDS ≤ -2.0) at screening according to the normal pediatric population standards\n5. Diagnosis of GHD confirmed by two different GH stimulation tests performed at screening or within 12 months prior to screening.\n6. No prior exposure to GH or IGF-1therapy.\n7. Absence of intracranial tumor, as confirmed by MRI or CT. Images or scans obtained within 1 year prior to screening can be used as screening data if accompanied by a medical evaluation and conclusion.\n8. AHV \\\u003C5 cm\u002Fyear at screening (Phase II only);\n9. BA \\\u003C CA at screening (Phase II only);\n10. IGF-1 SDS ≤ -1.0 at screening (Phase II only).\n\nExclusion Criteria:\n\n1. Presence of one or more pituitary hormone deficiencies in addition to growth hormone deficiency.\n2. Any suspected or known disease likely to affect growth, or any clinically significant abnormality that would preclude the accurate assessment of standing height (Phase II only), including but not limited to:\n\n   * Turner syndrome\n   * Noonan syndrome\n   * Laron Syndrome\n   * 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   * Born small for gestational age\n   * Growth retardation due to malnutrition\n   * Growth retardation due to hypothyroidism.\n   * Short stature with any other clearly identified etiology.\n   * Congenital abnormalities causing skeletal abnormalities, or claudication (Phase II only).\n   * Significant spinal abnormalities (Phase II only).\n3. Epiphyseal closure (Phase II only).\n4. Abnormal liver function, renal function, or coagulation profile\n5. Current or prior history of any malignant disease; or a family history of malignancy.\n6. Presence of impaired glucose metabolism, or HbA1c ≥ 5.7%, or a confirmed diagnosis of diabetes mellitus.\n7. 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.\n8. 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.\n9. A positive result for any of the following serological tests during the screening period: HBsAg, Anti-HCV, Anti-HIV, or TP-Ab.\n10. Known highly allergic diathesis or hypersensitivity to growth hormone products or any excipient of the investigational drug.\n11. 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.\n12. 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.\n13. Administration of any vaccine within 14 days prior to the first dose or planned vaccination at any time during the study period.\n14. The participant and\u002For the parent\u002Flegal representative is likely to be non-compliant with respect to study conduct, as judged by the investigator.\n15. 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).\n16. Children have been treated with inhaled glucocorticoid therapy at a dose greater than 400 µg\u002Fday of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening (Phase II only).\n17. Receipt within 3 months prior to screening or planned use during the study of medications that may interfere with growth or development (Phase II only).\n18. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.","ALL","3 Years","12 Years",{"count":20,"type":21},128,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study comprises two phases: Phase Ib and Phase II. Phase Ib is a multicenter, randomized, open-label, active-controlled, single-dose, dose-escalation to assess safety, tolerability, PK\u002FPD profile, and immunogenicity of GenSci134 in children with GHD.\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 GHD. It will also evaluate PK\u002FPD profile and immunogenicity to support dose selection for Phase III.",[28],"Pediatric Growth Hormone Deficiency",[30,31],"GenSci134","PGHD","NOT_YET_RECRUITING","2026-02-27",{"date":35,"type":36},"2026-03-04","ACTUAL",{"date":38,"type":21},"2026-03-06",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Changchun GeneScience Pharmaceutical Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":44},"100613285","phase-1-a-study-phase-1b2-of-gs3-007a-oral-treatment-in-children-with-growth-hormone-deficiency-pghd-100613285","NCT07264595","A Study (Phase 1b\u002F2) of GS3-007a Oral Treatment in Children With Growth Hormone Deficiency (PGHD)","A Study to Evaluate the Safety and Tolerability of Multiple Ascending Doses of GS3-007a Dry Suspension in Patients With PGHD and to Evaluate the Efficacy and Safety of 52-week of Treatment With GS3-007a Dry Suspension: a Two-part, Multicenter, Randomized, Phase Ib\u002FII Clinical Trial","Inclusion Criteria:\n\n* chronological age (CA) ≥3 years at Screening\n* Prepubertal girls or boys\n* Height at Screening lower than the reference height for normal children of the same chronological age and sex minus 2 standard deviations (-2 SD)\n* A confirmed diagnosis of growth hormone deficiency (GHD)\n* Having not been treated with any growth-promoting drugs\n* BA delayed by ≥6 months compared with the CA at Screening Subjects who meet all of the following criteria are eligible to enroll in the extension study (applicable for Part II extension period)\n* Subjects who have completed the 52-week treatment period of phase II\n* Subjects who do not permanently discontinue the investigational Medicinal Product (IMP) during the 52-week treatment period of phase II\n\nExclusion Criteria:\n\n* A highly allergic constitution\n* Suspected or confirmed total pituitary deficiency, including patients previously confirmed with deficiency of ≥2 pituitary hormones other than GH\n* Being confirmed with other chromosomal abnormalities or growth abnormalities affecting growth\n* Congenital skeletal dysplasia or serious spinal anomalies\n* Cognitive hypofunction, neurodevelopmental disorders, or psychiatric\u002Fpsychological disorders that, in the investigator's opinion, may interfere with evaluation of study endpoints\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Screening magnetic resonance imaging (MRI) scan of the sellar region confirming prior or current intracranial tumor growth\n* Concurrent use of any medications that may affect growth or response to growth hormone therapy\n* Epiphyseal closure\n* Electrocardiogram (ECG) QTcF interval abnormal, with a history of QT\u002FQTc interval prolonged\n* Hepatic function indicators abnormal at Screening Patients meeting any of the following criteria may not be enrolled in this extension study (applicable for Part II extension period)\n* Subjects with closed epiphyses\n* Any clinically significant abnormality that may affect growth or evaluation of the IMP\n* Known or suspected allergy to the IMP\n* Women with positive blood human chorionic gonadotropin (hCG) at the pre-treatment visit",{"count":53,"type":21},88,[24,25],"This is a two-part clinical study for children with growth hormone deficiency. In the first part, participants will be randomly assigned to receive different doses of an oral treatment (GS3-007a dry suspension) or a placebo for 14 days. This part is double-blinded, meaning neither the participants nor the doctors will know who is receiving the treatment or placebo. The goal is to find a safe and well-tolerated dose.\n\nIn the second part, participants will be randomly assigned to receive either the selected dose of GS3-007a or another approved treatment for 52 weeks. This part is open-label, so everyone will know which treatment is being given. After that, all participants may continue taking GS3-007a for another 156 weeks in an extension phase to study long-term effects.",[28],[58,31],"GS3-007a dry suspension","2025-11-24",{"date":61,"type":36},"2025-12-04",{"date":63,"type":21},"2025-12",{"date":65,"type":21},"2030-11",{"name":42,"class":43}]