[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602651":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":47,"centralContacts":56,"locations":66,"responsibleParty":264,"collaborators":42,"id":266,"slug":267,"hasResults":268,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":42,"eligibilityCriteria":272,"healthyVolunteers":268,"sex":273,"minAge":274,"maxAge":275,"enrollmentInfo":276,"targetDuration":42,"studyType":279,"phases":280,"briefSummary":283,"conditions":284,"keywords":288,"overallStatus":294,"whyStopped":42,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":305},{"fullName":5,"class":6},"Kexing Biopharm Co., Ltd.","INDUSTRY",[8,14,18,22,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"PhaseII GB08 0.4 mg\u002Fkg","EXPERIMENTAL","GB08 0.4mg\u002Fkg subcutaneous injection, once a week for 24 weeks",[13],"Drug: GB08",{"label":15,"type":10,"description":16,"interventionNames":17},"PhaseII GB08 0.8 mg\u002Fkg","GB08 0.8mg\u002Fkg subcutaneous injection, once a week for 24 weeks",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"PhaseII GB08 1.2 mg\u002Fkg","GB08 1.2mg\u002Fkg subcutaneous injection, once a week for 24 weeks",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"PhaseII Norditropin NordiFlex","ACTIVE_COMPARATOR","Norditropin NordiFlex 0.035 mg\u002Fkg subcutaneous injection, daily, for 24 weeks",[27],"Drug: Norditropin NordiFlex",{"label":29,"type":10,"description":30,"interventionNames":31},"PhaseIII GB08","GB08 subcutaneous injection (The dose will be determined by data from PhaseII), once a week for 52 weeks",[13],{"label":33,"type":24,"description":34,"interventionNames":35},"PhaseIII Norditropin NordiFlex","Norditropin NordiFlex 0.035 mg\u002Fkg subcutaneous injection, daily, for 52 weeks",[27],[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","GB08","In Phase II trial, eligible PGHD patients will receive GB08 0.4mg\u002Fkg, 0.8mg\u002Fkg, or 1.2mg\u002Fkg subcutaneous injection, once a week for 24 weeks.\n\nIn Phase III trial, the individuals will receive GB08 subcutaneous injection, once a week for 52 weeks. The dose of GB08 at this stage will be determined by the outcomes of Phase II.",[9,15,19,29],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Norditropin NordiFlex","Norditropin NordiFlex 0.035 mg\u002Fkg subcutaneous injection, daily, for 24 weeks (Phase II) or 52 weeks (Phase III)",[23,33],[48,52],{"name":49,"affiliation":50,"role":51},"Junfen Fu","The Children's Hospital of Zhejiang University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":54,"role":55},"Yijia Zhang","Shenzhen Kexing Pharmaceutical Co., Ltd.","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":42,"email":61},"Yanqing Lin","CONTACT","86-0755-23018589","linyanqing@kexing.com",{"name":63,"role":59,"phone":64,"phoneExt":42,"email":65},"Jinhai Lin","86-13760806104","linjinhai@kexing.com",[67,84,97,105,117,130,143,156,168,181,194,207,219,231,244,252],{"facility":68,"status":42,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Xiamen Maternal and Child Health Hospital","Xiamen","Fujian","361000","China","CN",{"type":75,"coordinates":76},"Point",[77,78],118.08187,24.47979,{"lat":78,"lon":77},[81],{"name":82,"role":83,"phone":42,"phoneExt":42,"email":42},"Xiaoqing Yang","SUB_INVESTIGATOR",{"facility":85,"status":42,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Nanyang Central Hospital","Nanyang","Henan","473000",{"type":75,"coordinates":90},[91,92],112.54659,33.00524,{"lat":92,"lon":91},[95],{"name":96,"role":83,"phone":42,"phoneExt":42,"email":42},"Na Xu",{"facility":98,"status":42,"city":86,"state":87,"zip":88,"country":72,"countryCode":73,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"The First Affiliated Hospital of Nanyang Medical College",{"type":75,"coordinates":100},[91,92],{"lat":92,"lon":91},[103],{"name":104,"role":83,"phone":42,"phoneExt":42,"email":42},"Xiaoxia Shi",{"facility":106,"status":42,"city":107,"state":87,"zip":108,"country":72,"countryCode":73,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"The Third Affiliated Hospital of Xinxiang Medical University","Xinxiang","453003",{"type":75,"coordinates":110},[111,112],113.80151,35.19033,{"lat":112,"lon":111},[115],{"name":116,"role":83,"phone":42,"phoneExt":42,"email":42},"Jinfen Han",{"facility":118,"status":42,"city":119,"state":120,"zip":121,"country":72,"countryCode":73,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Wuhan Children's Hospital","Wuhan","Hubei","430016",{"type":75,"coordinates":123},[124,125],114.26667,30.58333,{"lat":125,"lon":124},[128],{"name":129,"role":83,"phone":42,"phoneExt":42,"email":42},"Hui Yao",{"facility":131,"status":42,"city":132,"state":133,"zip":134,"country":72,"countryCode":73,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Suzhou University Children's Hospital","Suzhou","Jiangsu","215000",{"type":75,"coordinates":136},[137,138],120.59538,31.30408,{"lat":138,"lon":137},[141],{"name":142,"role":83,"phone":42,"phoneExt":42,"email":42},"Rongrong Xie",{"facility":144,"status":42,"city":145,"state":146,"zip":147,"country":72,"countryCode":73,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Jiangxi Children's Hospital","Nanchang","Jiangxi","330006",{"type":75,"coordinates":149},[150,151],115.85306,28.68396,{"lat":151,"lon":150},[154],{"name":155,"role":83,"phone":42,"phoneExt":42,"email":42},"Yu Yang",{"facility":157,"status":42,"city":158,"state":146,"zip":159,"country":72,"countryCode":73,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Pingxiang Maternal and Child Health Hospital","Pingxiang","337000",{"type":75,"coordinates":161},[162,163],113.85353,27.61672,{"lat":163,"lon":162},[166],{"name":167,"role":83,"phone":42,"phoneExt":42,"email":42},"Li Zhou",{"facility":169,"status":42,"city":170,"state":171,"zip":172,"country":72,"countryCode":73,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"The First Hospital of Jilin University","Changchun","Jilin","130021",{"type":75,"coordinates":174},[175,176],125.32278,43.88,{"lat":176,"lon":175},[179],{"name":180,"role":83,"phone":42,"phoneExt":42,"email":42},"Yining Zhang",{"facility":182,"status":42,"city":183,"state":184,"zip":185,"country":72,"countryCode":73,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Linyi Maternal and Child Health Hospital","Linyi","Shandong","276000",{"type":75,"coordinates":187},[188,189],118.34278,35.06306,{"lat":189,"lon":188},[192],{"name":193,"role":83,"phone":42,"phoneExt":42,"email":42},"Xiuying Ge",{"facility":195,"status":42,"city":196,"state":197,"zip":198,"country":72,"countryCode":73,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Chengdu Women's and Children's Central Hospital","Chengdu","Sichuan","610017",{"type":75,"coordinates":200},[201,202],104.06667,30.66667,{"lat":202,"lon":201},[205],{"name":206,"role":83,"phone":42,"phoneExt":42,"email":42},"Fang Tang",{"facility":208,"status":42,"city":209,"state":197,"zip":210,"country":72,"countryCode":73,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Meishan People's Hospital","Meishan","620010",{"type":75,"coordinates":212},[213,214],103.83696,30.04392,{"lat":214,"lon":213},[217],{"name":218,"role":83,"phone":42,"phoneExt":42,"email":42},"Yangfan Fei",{"facility":220,"status":42,"city":221,"state":197,"zip":222,"country":72,"countryCode":73,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"The Second People's Hospital of Yibin","Yibin","644000",{"type":75,"coordinates":224},[225,226],104.63994,28.7593,{"lat":226,"lon":225},[229],{"name":230,"role":83,"phone":42,"phoneExt":42,"email":42},"Lan Yao",{"facility":232,"status":42,"city":233,"state":234,"zip":235,"country":72,"countryCode":73,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Zhejiang Provincial People's Hospital","Hangzhou","Zhejiang","310014",{"type":75,"coordinates":237},[238,239],120.16142,30.29365,{"lat":239,"lon":238},[242],{"name":243,"role":83,"phone":42,"phoneExt":42,"email":42},"Qin Zhou",{"facility":245,"status":42,"city":233,"state":234,"zip":246,"country":72,"countryCode":73,"cosmosGeoPoint":247,"geoPoint":249,"contacts":250},"Children's Hospital of Zhejiang University School of Medicine","310051",{"type":75,"coordinates":248},[238,239],{"lat":239,"lon":238},[251],{"name":49,"role":51,"phone":42,"phoneExt":42,"email":42},{"facility":253,"status":42,"city":254,"state":234,"zip":255,"country":72,"countryCode":73,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Ningbo Women's and Children's Hospital","Ningbo","315010",{"type":75,"coordinates":257},[258,259],121.54945,29.87819,{"lat":259,"lon":258},[262],{"name":263,"role":83,"phone":42,"phoneExt":42,"email":42},"Shuxia Ding",{"type":265,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","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":277,"type":278},268,"ESTIMATED","INTERVENTIONAL",[281,282],"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.",[285,286,287],"Growth Hormone Deficiency in Children","Growth Hormone Deficiency (GHD)","Growth Hormone",[289,290,291,292,293],"growth hormone deficiency","annualized height velocity","growth hormone","clinical trial","GB08 injection","NOT_YET_RECRUITING","2025-08-17",{"date":297,"type":298},"2025-08-22","ACTUAL",{"date":300,"type":278},"2025-08-31",{"date":302,"type":278},"2028-12-23",{"name":54,"class":304},"NETWORK",16]