Osteomalacia ( DrugBank: - )
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 | 16 |
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 | NCT04842032 (ClinicalTrials.gov) | October 5, 2021 | 30/3/2021 | Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH | An Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Chinese Patients With X-linked Hypophosphatemic Rickets/Osteomalacia (XLH) | X-linked Hypophosphatemia (XLH) | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Recruiting | 1 Year | 12 Years | All | 28 | Phase 4 | China |
| 2 | NCT04842019 (ClinicalTrials.gov) | August 30, 2021 | 30/3/2021 | Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Adult Chinese Patients With XLH | An Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Adult Chinese Patients With X-linked Hypophosphatemic Rickets/Osteomalacia | X-linked Hypophosphatemia (XLH) | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | All | 18 | Phase 4 | China |
| 3 | NCT04045834 (ClinicalTrials.gov) | May 5, 2019 | 4/8/2019 | Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia | Study of the Diagnostic Value of Hybrid PET/MR and PET/CT in Neuroendocrine Diseases and Tumor Induced Osteomalacia | PET / CT;PET / MR;Neuroendocrine Tumors;Osteomalacia | Device: 68Ga-DOTA-TATE PET/MR and PET/CT imaging | Wuhan Union Hospital, China | NULL | Recruiting | 20 Years | 80 Years | All | 60 | China | |
| 4 | NCT03510455 (ClinicalTrials.gov) | February 27, 2019 | 26/4/2018 | BGJ398 for the Treatment of Tumor-Induced Osteomalacia | BGJ398 for the Treatment of Tumor-Induced Osteomalacia | Tumor-Induced Osteomalacia;Oncogenic Osteomalacia | Drug: BGJ398 | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Completed | 18 Years | 85 Years | All | 4 | Phase 2 | United States |
| 5 | NCT03736564 (ClinicalTrials.gov) | January 31, 2019 | 30/10/2018 | Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia | 68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia | Osteomalacia | Combination Product: 68Ga-DOTATATE PET/CT | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 6 | 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 | ||
| 7 | NCT04308096 (ClinicalTrials.gov) | January 9, 2018 | 26/2/2020 | A Study of KRN23 in Adult and Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia | A Phase 3 Long-term Extension Study of KRN23 in Patients With X-linked Hypophosphatemic Rickets/Osteomalacia | XLH | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Active, not recruiting | N/A | N/A | All | 27 | Phase 3 | Japan;Korea, Republic of |
| 8 | 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 | |||
| 9 | 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 |
| 10 | NCT03233126 (ClinicalTrials.gov) | July 6, 2017 | 11/7/2017 | 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 | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Completed | 1 Year | 12 Years | All | 16 | Phase 3 | Japan |
| 11 | NCT02722798 (ClinicalTrials.gov) | April 2016 | 7/3/2016 | A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome | 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 | Drug: KRN23 | Kyowa Kirin Co., Ltd. | NULL | Active, not recruiting | 18 Years | N/A | All | 6 | Phase 2 | Japan;Korea, Republic of |
| 12 | 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 | |
| 13 | 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 |
| 14 | NCT02181764 (ClinicalTrials.gov) | July 2014 | 2/7/2014 | A Study of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia | A Phase 1, Multicenter, Open-label, Sequential Dose-escalation, Single-dose Study to Assess the Safety and Tolerability of KRN23 in Subjects With X-linked Hypophosphatemic Rickets/Osteomalacia. | X-linked Hypophosphatemic Rickets/Osteomalacia | Drug: KRN23 | Kyowa Hakko Kirin Co., Ltd | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | Japan;Korea, Republic of |
| 15 | NCT01748812 (ClinicalTrials.gov) | November 16, 2012 | 11/12/2012 | Cinacalcet for Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia (Hypophosphatemic Rickets) | Open-label Dose-titration Study of the Tolerability and Efficacy of Cinacalcet to Treat Fibroblast Growth Factor 23 (FGF23)-Mediated Hypophosphatemia | Osteomalacia | Drug: Osteomalacia | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | 70 Years | All | 1 | Phase 1 | United States |
| 16 | ChiCTR-OOC-16010095 | 2006-01-01 | 2016-12-07 | Oral Phosphate Supplements Play an Important Role in Improving the Bone Mineral Density of Hypophosphatemic Osteomalacia Patients | Effect of Phosphate on hypophosphatemia | Hypophosphatemic Osteomalacia | A1:received phosphate solution doses at a frequency dependent upon measured serum phosphorus levels;A2:received phosphate solution doses only every three to four days;A3:received no phosphate solution;A:Hypophosphatemic Osteomalacia;B:Control; | The Second Xiangya Hospital, Central South University | NULL | Completed | Both | A1:3;A2:5;A3:3;A:21;B:105; | China |