Clinical Trial Details
| Trial ID: | L1685 |
| Source ID: | NCT03535415 |
| Associated Drug: | Recombinant Human Growth Hormone Injection (Rhgh) |
| Title: | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Short Stature Children Due to Chronic Kidney Disease Before Transplantation |
| Acronym: | |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Dwarfism |
| Interventions: | DRUG: Recombinant Human Growth Hormone Injection (rhGH) |
| Outcome Measures: | Primary: The change of height standard deviation score of chronological age before and after treatment (ΔHT SDS), 52 weeks，104 weeks | Secondary: Growth velocity, 365.25\*（height at the time of assessment -height at baseline）/duration of treatment(days), 12 months, 24 months|Bone maturation ( bone age/ chronological age: BA/CA), 12 months, 24 months|IGF-1 (Insulin-like growth factor 1) SDS, 12 months, 24 months|IGF-1/IGFBP-3 molar ratio, 12 months, 24 months |
| Sponsor/Collaborators: | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Collaborators: Children's Hospital of Fudan University|Beijing Children's Hospital|Shanghai Children's Hospital|Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine|The Children's Hospital of Zhejiang University School of Medicine|Children's Hospital of The Capital Institute of Pediatrics|Peking University First Hospital|Fuzhou General Hospital|The First Affiliated Hospital of Zhengzhou University|Shengjing Hospital|Children's Hospital of Chongqing Medical University|Tongji medical college huazhong university of science & technology |
| Gender: | ALL |
| Age: | CHILD |
| Phases: | PHASE3 |
| Enrollment: | 68 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2018-06-25 |
| Completion Date: | 2021-09 |
| Results First Posted: | |
| Last Update Posted: | 2018-11-23 |
| Locations: | Fuzhou general hospital of Nanjing military command, Fuzhou, Fujian, China|The first affiliated hospital of zhengzhou university, Zhengzhou, Henan, China|Tongji medical college huazhong university of science & technology, Wuhan, Hubei, China|Shengjing hospital of chian medical university, Shenyang, Liaoning, China|Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China|The Children's Hospital ,Zhejiang University School of Medicine, Hangzhou, Zhejiang, China|Beijing Children's Hospital, Capital Medical University, Beijing, China|Children's hospital capital institute of pediatrics, Beijing, China|Peking university first hospital, Beijing, China|Children's hospital of Chongqing medical university, Chongqing, China|Children's Hospital of Fudan University, Shanghai, China|Children's Hospital of Shanghai, Shanghai, China |
| URL: | https://clinicaltrials.gov/show/NCT03535415 |
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