Pilot of Abatacept-based Immunosuppression for Prevention of Acute GvHD During Unrelated Donor HCT...
AMLALL11 moreThe primary objective of the study is to determine the safety and tolerability when adding abatacept to acute Graft versus Host Disease in transplants for malignant diseases using unrelated donor bone marrow or peripheral blood stem cell grafts.
Eltrombopag for Post Transplant Thrombocytopenia
ThrombocytopeniaThe goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.
Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
PurpuraThrombocytopenic3 moreThis will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation [CV]%) of approximately 35%.
Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic...
HematologyMDS2 moreThis is an open label extension study of romiplostim for treatment of thrombocytopenia (platelet count ≤ 50 x 10^9/L) in MDS subjects. The study is designed to assess the long-term safety of treatment with romiplostim, as measured by incidence of overall adverse events, the incidence of bleeding events, the utilization of platelet transfusions, and the duration of platelet response. The study will further describe the time to disease progression to acute myeloid leukemia (AML) and survival.
Once-Daily Oral Avatrombopag Tablets Used in Subjects With Chronic Liver Diseases and Thrombocytopenia...
Thrombocytopenia Related to Chronic Liver DiseaseThe purpose of this study is to evaluate the efficacy of once-daily Oral avatrombopagin subjects with chronic liver diseases and thrombocytopenia prior to elective surgical or diagnostic procedures, to evaluate the safety of short-term administration of avatrombopag and to evaluate the pharmacokinetics (PK) of E5501.
Rituximab as Second Line Treatment for ITP
Immune Thrombocytopenia (ITP)Immune thrombocytopenic purpura (ITP) is an autoimmune disorder characterized thrombocytopenia. Splenectomy is the standard treatment for patients who fails the first-line treatment: corticosteroid. Rituximab, has recently emerged as a promising treatment for ITP. The aim of the study is to determine whether early treatment with Rituximab can result in durable remissions, and consequently, lead to the avoidance of splenectomy in a significant number of patients.
Safety and Performance of MIRASOL® PRT Treated Platelet Transfusion Products
ThrombocytopeniaThe primary objective of the study is to measure platelet corrected count increments and the incidence of serious adverse events (SAE). The primary endpoint is the platelet corrected count increment measured 1-hour post transfusion in response to the infusion of platelet concentrates treated with the Mirasol PRT System device (test product) versus untreated (reference product).
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura...
ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraThe purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura...
ThrombocytopeniaIdiopathic Thrombocytopenic PurpuraThe purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response. This study will also evaluate changes in Patient Reported Outcomes and Health Resource Utilization due to treatment with AMG 531.
Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment...
ITPThis is a review of the efficacy and safety of different recombinant human thrombopoietin (rhTPO) regimens in the treatment of patients with primary immune thrombocytopenia (ITP).