Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-26 @ 1:51 PM
Study NCT ID:
NCT05353192
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2022-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000130', 'term': 'Achondroplasia'}], 'ancestors': [{'id': 'D004392', 'term': 'Dwarfism'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010009', 'term': 'Osteochondrodysplasias'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-26', 'studyFirstSubmitDate': '2022-04-25', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Metabolism-related Proteins', 'timeFrame': 'week 13, week 26, week 52', 'description': 'Change From Baseline in Serum Proteomics at week 13, week 26, week 52'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Annualized Height Velocity (AHV) at Week 52', 'timeFrame': 'week 52', 'description': 'The change in AHV after 52 weeks treatment'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in AHV', 'timeFrame': 'week 4, week 13, week 26, week 39', 'description': 'Change in AHV at week, week 13, week 26, week 39'}, {'measure': 'Change From Baseline in Height Standard Deviation Score (Ht SDS)', 'timeFrame': 'week 4, week 13, week 26, week 39, week 52', 'description': 'Change From Baseline in Ht SDS at week 4, week 13, week 26, week 39, week 52'}, {'measure': 'Change From Baseline in BMI Standard Deviation Score (BMI SDS)', 'timeFrame': 'week 4, week 13, week 26, week 39, week 52', 'description': 'Change From Baseline in BMI SDS at week 4, week 13, week 26, week 39, week 52'}, {'measure': 'Change From Baseline in Sitting Height/Leg Length ratio Standard Deviation Score (SH/LL SDS)', 'timeFrame': 'week 4, week 13, week 26, week 39, week 52', 'description': 'Change From Baseline in SH/LL SDS at week 4, week 13, week 26, week 39, week 52'}, {'measure': 'Change From Baseline in IGF-1 Standard Deviation Score (IGF -1 SDS)', 'timeFrame': 'week 4, week 13, week 26, week 39, week 52', 'description': 'Change From Baseline in IGF-1 SDS at week 4, week 13, week 26, week 39, week 52'}, {'measure': 'Change From Baseline in IGF-1/IGFBP-3 ratio', 'timeFrame': 'week 4, week 13, week 26, week 39, week 52', 'description': 'Change From Baseline in IGF-1/IGFBP-3 ratio at week 4, week 13, week 26, week 39, week 52'}, {'measure': 'Change From Baseline in Bone Age/Chronological Age ratio (BA/CA)', 'timeFrame': 'week 52', 'description': 'Change From Baseline in BA/CA at week 52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Achondroplasia'], 'conditions': ['Achondroplasia']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children with Achondroplasia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2-10 years old;\n* In Tanner I stage;\n* ACH, documented and confirmed by genetic testing;\n* Short stature;\n* Ambulatory and able to stand or walk without assistance;\n* Parent(s) or guardian(s) consent；\n* Had never been treated with growth hormone\n\nExclusion criteria:\n\n* Short stature condition other than ACH;\n* Evidence of growth plate closure (proximal tibia, distal femur);\n* Had a fracture of the long bones within 6 months prior to screening;\n* Planned or expected bone-related surgery;\n* Chronic diseases condition that affect bone metabolism and weight;\n* Severe intracranial hypertension'}, 'identificationModule': {'nctId': 'NCT05353192', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Changchun GeneScience Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Open-label, Single Arm Phase IV Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia', 'orgStudyIdInfo': {'id': 'GenSci001-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant human growth hormone', 'description': 'Recombinant human growth hormone Injection (15IU/5mg/3ml/bottle)；0.05 mg/kg/d by subcutaneous injection for 52 weeks', 'interventionNames': ['Drug: Recombinant human growth hormone']}], 'interventions': [{'name': 'Recombinant human growth hormone', 'type': 'DRUG', 'description': 'Recombinant human growth hormone (15IU/5mg/3ml/bottle)，0.05 mg/kg/d by subcutaneous injection for 52 weeks', 'armGroupLabels': ['Recombinant human growth hormone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Feihong Luo', 'role': 'CONTACT', 'email': 'luo_fh@163.com', 'phone': '18017590900'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yanru Wu', 'role': 'CONTACT', 'email': 'wuyanru@gensci-china.com', 'phone': '+86 15843110489'}], 'overallOfficials': [{'name': 'Feihong Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}, {'name': 'Xiaoping Luo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tongji Hospital'}, {'name': 'Wei Gu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Nanjing Medical University"}, {'name': 'Yu Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Jiangxi Province Children's Hospital"}, {'name': 'Xinran Cheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Chengdu Women's and Children's Central Hospital"}, {'name': 'Guimei Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Provincial Hospital'}, {'name': 'Ying Xin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital of China Medical Hospital'}, {'name': 'Pin Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai Children's Hospital"}, {'name': 'Xiaobo Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of The Capital Institute of Pediatrics"}, {'name': 'Jin Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West China Second University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Drugs belong to the sponsor before they are put into clinical trials and the site is only a contract research organization; It is an industry practice that intellectual property rights belong to the sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changchun GeneScience Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': "Children's Hospital of Nanjing Medical University", 'class': 'OTHER'}, {'name': "Jiangxi Province Children's Hospital", 'class': 'OTHER'}, {'name': "Chengdu Women's and Children's Central Hospital", 'class': 'OTHER'}, {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': "Shanghai Children's Hospital", 'class': 'OTHER'}, {'name': "Children's Hospital of The Capital Institute of Pediatrics", 'class': 'OTHER'}, {'name': 'West China Second University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}