[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"growth-hormone\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:growth-hormone":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100602651","phase-2-evaluating-the-efficacy-and-safety-of-gb08-injection-in-pediatric-patients-with-growth-hormone-deficiency-100602651",false,"NCT07126288","Evaluating the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency","A Phase II\u002FIII, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial to Evaluate the Efficacy and Safety of GB08 Injection in Pediatric Patients With Growth Hormone Deficiency","Inclusion Criteria:\n\n1\\. Diagnosed with Growth Hormone Deficiency (GHD) based on medical history, clinical symptoms and signs, GH stimulation tests, and imaging studies. The participant must meet the following:\n\n1. Absolute height 2 standard deviations (SD) below the mean height of children of the same age and sex, according to the standardized growth curves for children and adolescents in China (0-18 years old) published in 2009.\n2. Annualized height velocity (AHV) ≤ 5.0 cm\u002Fyear, calculated from measurement of 6 to 18 months before screening.\n3. GH peak ≤ 10 ng\u002Fml proved by two different GH stimulation tests within a year before screening.\n4. Bone age lagging at least 1 year behind actual age (bone age assessment within the past 6 months before screening), with girls \\\u003C 10 years old and boys \\\u003C 11 years old.\n\n2\\. Aging \\> 3 years and ≤ 10 years (girls) or ≤ 11 years (boys) based on birth date; Tanner stage I (testicular volume \\\u003C 4 ml for boys and no palpable breast tissue for girls) 3. Uniform short stature with normal intellectual development. 4. IGF-1 levels below the mean for children and adolescents of the same age and sex, at least 1 SD below (IGF-1 SDS ≤ -1.0).\n\n5\\. Body mass index (BMI) within ±2 SD of the mean BMI for children and adolescents of the same age and sex.\n\n6\\. For subjects with GHD as part of multiple pituitary hormone deficiencies, must be stable for ≥1 month, as determined by the investigator.\n\n7\\. Guardians understand and sign the Informed Consent Form (ICF). If the participant is ≥8 years old, they must also sign the ICF. For participants \\\u003C8 years old who can express consent, their consent must be recorded.\n\nExclusion Criteria:\n\n1. History of systematic growth-promoting therapy, including growth hormone and sex hormones.\n2. Severe allergic constitution or known allergy to growth hormone or its excipients, such as mannitol, lysine, or sodium chloride.\n3. Closed epiphyses.\n4. Other types of growth disorders such as idiopathic short stature, Turner syndrome, Noonan syndrome, Prader-Willi syndrome, and Russell-Silver syndrome.\n5. Short stature due to other causes, such as intrauterine growth restriction, familial short stature, thyroid hormone deficiency, adrenal insufficiency, antidiuretic hormone deficiency, celiac disease, rickets, psychological factors, chronic kidney disease, infections, or trauma.\n6. Any clinically significant abnormalities that may affect growth or growth assessment; subjects with liver or kidney dysfunction (ALT \\> 1.5 times upper limit of normal, creatinine \\> upper limit of normal), chronic diseases (malnutrition, fasting blood glucose ≥ 126 mg\u002FdL or HbA1c ≥ 6.5%), diabetes, severe cardiac, pulmonary, hematological, or systemic infections, immunodeficiency, psychiatric disorders, or congenital malformations.\n7. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, or tuberculosis (HBV surface antigen-positive subjects must undergo HBV DNA testing; HCV antibody-positive subjects must undergo HCV RNA testing; if HBV DNA or HCV RNA \\> detection limit, they are excluded).\n8. Use of corticosteroids or other steroids within the past 12 months, such as long-term steroid use for asthma.\n9. History of pituitary or hypothalamic tumors, or other intracranial tumors on MRI; history of leukemia, lymphoma, or other malignancies.\n10. History of radiation therapy or chemotherapy.\n11. Congenital intracranial hypertension.\n12. Femoral head slipped epiphysis (SCFE).\n13. Spinal scoliosis \\> 15°.\n14. Participation in any other drug clinical trial within the past 3 months (as a subject).\n15. Other factors deemed unsuitable for participation in the study by the investigator.","ALL","3 Years","11 Years",{"count":20,"type":21},268,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This study aims to evaluate the efficacy and safety of GB08 injection compared to Norditropin NordiFlex in pediatric patients with growth hormone deficiency (PGHD). It seeks to resolve the following questions:\n\n* 1: Does GB08 injection demonstrate comparable efficacy in treating PGHD at 24 weeks compared to Norditropin NordiFlex?\n* 2: Which dose (0.4 mg\u002Fkg, 0.8 mg\u002Fkg, and 1.2 mg\u002Fkg) of GB08 injection best balances efficacy and safety in treating PGHD at 24 weeks?\n* 3: Does GB08 injection maintain its efficacy in treating PGHD at 52 weeks compared to Norditropin NordiFlex? To achieve these, GB08 injection will be compared to Norditropin NordiFlex to see if it provides a more effective or safer treatment option for PGHD.\n\nThis is a Phase II\u002FIII, Seamless, Multicenter, Randomized, Open-Label, Positive-Comparator Controlled Clinical Trial with two stages. Stage 1 answers questions #1 and #2 by comparing the efficacy and safety of GB08 injection and Norditropin NordiFlex intervention among PGHD at 24 weeks. It involves four groups (n=16 each): GB08 0.4 mg\u002Fkg, GB08 0.8 mg\u002Fkg, GB08 1.2 mg\u002Fkg, and Norditropin NordiFlex 0.035 mg\u002Fkg. GB08 and Norditropin NordiFlex will be administered once weekly and once daily, respectively. The primary outcome measurement is annualized height velocity (AHV) at 24 weeks. Other measurements include growth hormone levels, safety parameters, immunogenicity markers, and pharmacokinetic\u002Fpharmacodynamic profiles.\n\nThe optimal GB08 dose will be further investigated in Stage 2, which answers question #3. At this stage, PGHD patients will randomly receive either GB08 injection or Norditropin NordiFlex intervention for 52 weeks (n=102 for each). After that, the efficacy and safety of GB08 will also be detected.",[28,29,30],"Growth Hormone Deficiency in Children","Growth Hormone Deficiency (GHD)","Growth Hormone",[32,33,34,35,36],"growth hormone deficiency","annualized height velocity","growth hormone","clinical trial","GB08 injection","NOT_YET_RECRUITING","2025-08-17",{"date":40,"type":41},"2025-08-22","ACTUAL",{"date":43,"type":21},"2025-08-31",{"date":45,"type":21},"2028-12-23",{"name":47,"class":48},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",16,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100473616","phase-3-effect-of-gh-on-the-blastocyst-euploid-rate-in-ama-patients-100473616","NCT05447208","Effect of GH on the Blastocyst Euploid Rate in AMA Patients","A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age","Inclusion Criteria:\n\n* Age ≥38; intended to undergo PGT-A\n* BMI in the normal range (18.50-24.0kg\u002Fm2)\n* Normal semen analysis for the male partner\n\nExclusion Criteria:\n\n* Endometriosis grade 3 or higher, untreat hydrosalpinx\n* Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)\n* Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease\n* History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia\n* History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.","FEMALE","38 Years",{"count":60,"type":21},400,[25],"This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement.\n\nInfertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:\n\nTreatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation.\n\nControl group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.",[64,30,65],"Preimplantation Genetic Testing","Age, Parental","RECRUITING","2025-02-07",{"date":69,"type":41},"2025-02-12",{"date":71,"type":41},"2022-08-01",{"date":73,"type":21},"2026-12-31",{"name":75,"class":76},"ShangHai Ji Ai Genetics & IVF Institute","OTHER",1]