Blood
01 Jan 2013
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL)
The purpose of this study is to provide treatment for patients who have CLL, and to compare the use of rituximab added to FC with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms. Official Title Open-Label, Multicenter, Randomized, Comparative, Phase III Study…
Blood
01 Jan 2013
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A. Official…
Blood
01 Jan 2013
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections (BI) or continuous infusion (CI). Official Title An Open Label Multi-Center Study to Assess the Efficacy and Safety of B-Domain…
Blood
01 Jan 2013
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients
The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH Official Title Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients Conditions Hemoglobinuria, Paroxysmal Study Type Interventional Study Design Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study…
Blood
01 Jan 2013
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia
This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining…
Blood
01 Jan 2013
Super High-Flux – High Volume Dialysis in Sepsis-Induced Acute Renal Failure
We wish to compare the effect of using new large hole filters with hemodialysis in patients with severe infections and acute kidney failure to that of standard filters. The new therapy will be considered to be effective if it lowers the amount of drugs used to support blood pressure and…
Blood
01 Jan 2013
Trial to Reduce Cardiovascular Events With ‘Aranesp’ Therapy (TREAT)
The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa on mortality and cardiovascular morbidity in patients with chronic kidney disease and type 2 diabetes. Official Title Conditions Kidney Disease, Nephritis, Diabetes Mellitus, anaemia Study Type Interventional Study Design Treatment Further Details Primary…
Blood
01 Jan 2013
A Prospective, Surveillance Study to Estimate the Incidence of Pure Red Blood Cell Aplasia (Aplastic Anemia) Mediated by Erythropoietin Antibodies Among Patients With Chronic Kidney Failure and Subcutaneous Exposure to Recombinant Erythropoietin Prod
The purpose of this study is to estimate the incidence rate of pure red cell aplasia (PRCA; aplastic anemia) mediated by erythropoietin (EPO) antibodies in patients who are receiving subcutaneous (s.c.) EPREX (polysorbate 80 formulation) for the treatment of anemia associated with chronic renal failure (CRF), and to compare this…
Blood
01 Jan 2013
Comparison between Cy then G-CSF and IVE Plus G-CSF in Haematological Malignancies
Aim: To retrospectively compare the PBPC yields of harvests after IVE with those of standard Cy/G-CSF priming. Conclusions: Priming with IVE yields higher PBPC numbers than cyclophosphamide, patients requiring fewer pheresis, therefore reducing the cost. Official Title A Retrospective Comparison between Cyclophosphamide (Cy) Followed by G-CSF, and…