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A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

2019-10-29 14:36:35 | BioPortfolio

Summary

The primary objectives of this study are:

- To establish the efficacy of fostamatinib in placebo crossover subjects with warm antibody autoimmune hemolytic anemia (wAIHA)

- To determine the ability to maintain a response in subjects receiving fostamatinib for wAIHA

Study Design

Conditions

Warm Antibody Autoimmune Hemolytic Anemia

Intervention

Fostamatinib disodium

Status

Not yet recruiting

Source

Rigel Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-29T14:36:35-0400

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A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

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Warm Autoimmune Hemolytic Anemia.

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Erythrophagocytosis on bone marrow found in severe autoimmune hemolytic anemia with reticulocytopenia.

Medical and Biotech [MESH] Definitions

Acquired hemolytic anemia due to the presence of AUTOANTIBODIES which agglutinate or lyse the patient's own RED BLOOD CELLS.

Hemagglutination test in which Coombs' reagent (antiglobulin, or anti-human globulin rabbit immune serum) is added to detect incomplete (non-agglutinating, univalent, blocking) antibodies coating erythrocytes. The direct test is applied to red cells which have been coated with antibody in vivo (e.g., in hemolytic disease of newborn, autoimmune hemolytic anemia, and transfusion reactions). The indirect test is applied to serum to detect the presence of antibody (e.g., in detection of incompatibility in cross-matching tests, detection and identification of irregular antibodies, and in detection of antibodies not identifiable by other means).

A syndrome that is associated with microvascular diseases of the KIDNEY, such as RENAL CORTICAL NECROSIS. It is characterized by hemolytic anemia (ANEMIA, HEMOLYTIC); THROMBOCYTOPENIA; and ACUTE RENAL FAILURE.

Hemolytic anemia due to various intrinsic defects of the erythrocyte.

A condition characterized by the abnormal presence of ERYTHROBLASTS in the circulation of the FETUS or NEWBORNS. It is a disorder due to BLOOD GROUP INCOMPATIBILITY, such as the maternal alloimmunization by fetal antigen RH FACTORS leading to HEMOLYSIS of ERYTHROCYTES, hemolytic anemia (ANEMIA, HEMOLYTIC), general edema (HYDROPS FETALIS), and SEVERE JAUNDICE IN NEWBORN.

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An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

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