Burosumab ( DrugBank: Burosumab )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 238 | ビタミンＤ抵抗性くる病/骨軟化症 | 8 |
238. ビタミンＤ抵抗性くる病/骨軟化症
臨床試験数 : 29 / 薬物数 : 25 - (DrugBank : 11) / 標的遺伝子数 : 4 - 標的パスウェイ数 : 20
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04159675 (ClinicalTrials.gov) | October 1, 2020 | 7/11/2019 | Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts | Effect of Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts From Patients Requiring Craniosynostosis Surgery for Idiopathic Reason or Due to Hypophosphatemic Rickets (HR) | Craniosynostoses | Biological: osteoblast biology study | Hospices Civils de Lyon | NULL | Not yet recruiting | 4 Months | 18 Years | All | 20 | France | |
| 2 | NCT04320316 (ClinicalTrials.gov) | July 31, 2020 | 11/3/2020 | A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS) | An Open Label Trial to Assess the Safety and Efficacy of KRN23, an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome (ENS) and Associated Hypophosphatemic Rickets | Epidermal Nevus Syndrome | Drug: Crysvita (burosumab-twza) Treatment | University of Alabama at Birmingham | Ultragenyx Pharmaceutical Inc | Completed | 6 Months | N/A | Male | 1 | Phase 4 | United States |
| 3 | NCT03581591 (ClinicalTrials.gov) | January 31, 2018 | 27/10/2017 | Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets | An Open Label Trial to Assess the Safety and Efficacy of Burosumab (KRN23), an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome(ENS) and Associated Hypophosphatemic Rickets | Hypophosphatemia;Hypophosphatemic Rickets;Pain, Chronic | Biological: Burosumab | Redwood Dermatology Sciences | Ultragenyx Pharmaceutical Inc | Completed | N/A | 18 Years | Female | 1 | Phase 3 | United States |
| 4 | JPRN-JapicCTI-205284 | 09/1/2018 | 11/05/2020 | A Study of KRN23 in Adult and Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | Phase 3 Long-term Extension Study of KRN23 in Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | Adult or pediatric XLH | Intervention name : burosumab INN of the intervention : KRN23 Dosage And administration of the intervention : repeated SC administration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | BOTH | 27 | Phase 3 | Japan, Asia except Japan | ||
| 5 | NCT03775187 (ClinicalTrials.gov) | January 4, 2018 | 11/12/2018 | Expanded Access to Burosumab | X-linked Hypophosphatemia;Tumor-Induced Osteomalacia | Biological: Burosumab | Ultragenyx Pharmaceutical Inc | Kyowa Kirin Co., Ltd. | Available | N/A | N/A | All | NULL | |||
| 6 | JPRN-JapicCTI-173614 | 31/7/2017 | 15/06/2017 | A Study of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | A Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia | X-linked Hypophosphatemic Rickets/Osteomalacia | Intervention name : KRN23 INN of the intervention : burosumab Dosage And administration of the intervention : repeated SC administration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | 1 | 12 | BOTH | 10 | Phase 3 | Japan |
| 7 | JPRN-JapicCTI-163191 | 23/4/2015 | 08/03/2016 | A Phase 2 Open-Label Trial of KRN23 | A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients with Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | Intervention name : KRN23 INN of the intervention : burosumab Dosage And administration of the intervention : repeated SC administration, intraindividual dose adjustment Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Kyowa Kirin Co., Ltd. | NULL | complete | 18 | BOTH | 6 | Phase 2 | Japan, Asia except Japan | |
| 8 | NCT02304367 (ClinicalTrials.gov) | March 24, 2015 | 24/11/2014 | Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS) | A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated Osteomalacia | Tumor Induced Osteomalacia (TIO);Epidermal Nevus Syndrome (ENS) | Biological: Burosumab | Ultragenyx Pharmaceutical Inc | NULL | Active, not recruiting | 18 Years | N/A | All | 17 | Phase 2 | United States |