Searched query = "Aplastic anemia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
|1||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)||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|
|December 2, 1999||18/1/2000||Combination Therapy of Severe Aplastic Anemia||Treatment of Severe Aplastic Anemia With Combined Immunosuppression: Antithymocyte Globulin (ATG) and Cyclosporine A (CSA), and Mycophenolate Mofetil (MMF)||Severe Aplastic Anemia||Drug: Cyclosporine A;Drug: ATG;Drug: MMF||National Heart, Lung, and Blood Institute (NHLBI)||NULL||Completed||1 Year||99 Years||All||104||Phase 2||United States|