[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"growth-hormone-deficiency-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:growth-hormone-deficiency-in-children":28},{"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":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100635489","phase-3-gb06-phase-iii-trial-for-pediatric-growth-hormone-deficiency-100635489",false,"NCT07553351","GB06 Phase III Trial for Pediatric Growth Hormone Deficiency","A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Trial to Study the Efficacy and Safety of Human Growth Hormone Injection (GB06) in Treating Growth Disorders Caused by Pediatric Growth Hormone Deficiency","Inclusion Criteria:\n\n1. The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.\n2. Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);\n3. Height below two standard deviations (SD) of the average height of children of the same age and gender;\n4. Annual height velocity (AHV) \\\u003C5cm\u002Fyear, based on height within 6 months to 18 months before screening;\n5. Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;\n6. Short stature with normal intellectual development;\n7. Tanner stage I (testicular volume \\\u003C4ml for boys, no palpable breast gland tissue for girls);\n8. IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;\n9. Bone age lags behind the chronological age;\n10. Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng\u002Fml;\n11. A standard karyotype of 46, XX for girls.\n\nExclusion Criteria:\n\n1. Known allergy to ingredients of the study drug;\n2. Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;\n3. Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;\n4. Small for gestational age;\n5. Epiphyseal closure;\n6. Congenital intracranial hypertension;\n7. Slipped capital femoral epiphysis;\n8. GHD secondary to another pituitary hormone deficiency;\n9. Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;\n10. History of fundus lesions (optic nerve papilledema lesions);\n11. Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol\u002FL or hemoglobin A1c (HbA1c) ≥ 6.5%;\n12. Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;\n13. Expected requirement to inhale budesonide \\>400μg\u002Fday or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;\n14. Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene abnormality, GH receptor deletion, or other significant genetic mutations causing short stature; Significant spinal abnormalities, including but not limited to scoliosis, kyphosis, and spina bifida; Congenital anomalies (resulting in skeletal abnormalities), including but not limited to Russell-Silver syndrome and bone dysplasia; Family history of bone dysplasia;\n15. Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction \\[e.g., alanine aminotransferase (ALT)\\> 1.5 times the upper limit of normal, creatinine (Cr) \\>upper limit of normal value\\], malnutrition, severe cardiopulmonary and hematological diseases, systemic infection, immunodeficiency, mental abnormalities, and other congenital malformations;\n16. Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, and tuberculosis. Hepatitis B virus DNA levels will be assessed in individuals who are positive for HBV surface antigen.\n\n    A hepatitis C virus RNA test is required if the hepatitis C virus antibody test is positive. Quantitative results below the lower limit of detection will be excluded.\n17. Concomitant use of other treatments that may affect growth, including but not limited to methylphenidate for attention deficit hyperactivity disorder;\n18. History of drug or alcohol abuse;\n19. Children with hypothyroidism and\u002For adrenal insufficiency who have not received adequate stable replacement therapy lasting at least 90 days before randomization;\n20. Other diseases that the investigator believes may endanger the safety of the participant or protocol compliance;\n21. Potentially poor compliance in this study.\n22. Other conditions that the investigator deems unsuitable for inclusion.","ALL","3 Years","11 Years",{"count":20,"type":21},192,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children.\n\nIt aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg\u002Fkg\u002Fday for 52 consecutive weeks.",[27,28,29],"Growth Hormone Deficiency (GHD)","Growth Hormone Deficiency in Children","Growth Hormone Deficiency, Pediatric",[31,32,33,34,35,36],"Growth Hormone","Growth Hormone Deficiency","Annual Height Velocity","Insulin-like Growth Factor-1","Bone Age","GB06","RECRUITING","2026-06-07",{"date":40,"type":41},"2026-06-10","ACTUAL",{"date":43,"type":41},"2026-06-06",{"date":45,"type":21},"2028-10-24",{"name":47,"class":48},"Kexing Biopharm Co., Ltd.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100602651","phase-2-evaluating-the-efficacy-and-safety-of-gb08-injection-in-pediatric-patients-with-growth-hormone-deficiency-100602651","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.",{"count":58,"type":21},268,[60,24],"PHASE2","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.",[28,27,31],[64,65,66,67,68],"growth hormone deficiency","annualized height velocity","growth hormone","clinical trial","GB08 injection","NOT_YET_RECRUITING","2025-08-17",{"date":72,"type":41},"2025-08-22",{"date":74,"type":21},"2025-08-31",{"date":76,"type":21},"2028-12-23",{"name":78,"class":79},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",16]