60. 再生不良性貧血 Aplastic anemia Clinical trials / Disease details
臨床試験数 : 245 / 薬物数 : 318 - (DrugBank : 86) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 166
| 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 | NCT03520647 (ClinicalTrials.gov) | February 19, 2019 | 9/5/2018 | Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis | Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis | Severe Aplastic Anemia (SAA);Hypo-Plastic Myelodysplastic Syndrome (MDS);Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: Cyclophosphamide;Other: Peripheral Blood Stem Cells | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Recruiting | 4 Years | 75 Years | All | 56 | Phase 2 | United States |
| 2 | NCT03295058 (ClinicalTrials.gov) | January 1, 2019 | 24/9/2017 | Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin Regimens in Severe Aplastic Anemia Patients | Outcome of Peripheral Blood Allogenic Stem Cell Transplantation Using Non-anti Thymocyte Globulin (ATG ) Conditioning Regimens in Severe Aplastic Anemia Patients | Severe Aplastic Anemia | Drug: Non ATG Conditioning regimen;Drug: GVHD Prophylaxis;Procedure: Allogenic Stem Cell Transplantation;Drug: ATG conditioning regimen | Assiut University | NULL | Unknown status | 16 Years | 50 Years | All | 50 | Phase 2/Phase 3 | NULL |
| 3 | NCT02065154 (ClinicalTrials.gov) | August 27, 2013 | 5/11/2013 | Post Transplant Cyclophosphamide (Cytoxan) for GvHD Prophylaxis | Phase II Clinical Trial of the Use of Post-Transplant Cyclophosphamide for Graft Versus Host Disease (GvHD) Prophylaxis Following Matched Unrelated Donor (MUD) and Mismatched Unrelated Donor (MMUD)Hematopoietic Stem Cell Transplant (HSCT) | Leukemia;Lymphoma;Myelodysplastic Syndrome;Myelofibrosis;Severe Aplastic Anemia;Allogeneic Transplant | Drug: Cyclophosphamide | University of Alabama at Birmingham | NULL | Active, not recruiting | 19 Years | 65 Years | All | 41 | Phase 2 | United States |
| 4 | JPRN-UMIN000004264 | 2010/11/01 | 01/11/2010 | A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) | A Pharmacokinetics (PK)/Phase I study of intravenous (i.v.) administration of mycophenolate mofetil (MMF) for graft-versus-host disease (GVHD) prophylaxis after allogeneic hematopoietic stem cell transplantation (allo-SCT) - A PK/Phase I study of i.v. MMF for GVHD prophylaxis | Refractory hematologic disorders, including1. Acute myelogenous leukemia2. Acute lymphoblastic leukemia3. Myelodysplastic syndrome4. Chronic myelogenous leukemia5. Malignant lymphoma6. Aplastic anemia | For GVHD prophylaxis, MMF is administered 4-6 h after allo-SCT at a dose of 1000 mg i.v. (diluted to a concentration of 6 mg/ml using 5% Dextrose, over 2 h) thrice daily (or twice daily in the case of cord blood transplantation) from day 0 to day 10 (for up to 14 days). Thereafter, patients are changed to p.o. MMF at the same dose and interval. After day 31, the dose tapers depending on individual risk factors for GVHD. Blood samples (2 ml) for PK analysis are collected in EDTA tubes at 0, 0.5, 1, 2, 4, 8, and 12 h after the morning dose on days 2 and 9 during i.v. MMF administration and at 0, 1, 2, 4, 8, and 12 h on day 16 during p.o. MMF administration. Total mycophenolic acid (MPA) levels are quantified by reverse-phase HPLC. After quantification, non-compartmental analyses of total MPA concentration time data are conducted to estimate the AUC. | Kobe University Graduate School of Medicine | School of Pharmacy and Pharmaceutical Science, Mukogawa Women's University | Complete: follow-up complete | 15years-old | 69years-old | Male and Female | 10 | Phase 1 | Japan |