Alexion ) announced that the pivotal Phase 3 study of ALXN1210, the company's investigational long-acting C5 complement inhibitor, demonstrated non-inferiority to Soliris in complement inhibitor treatment-naive patients with paroxysmal nocturnal hemoglobinuria based on the co-primary endpoints of transfusion avoidance and normalization of lactate dehydrogenase levels, a direct marker of complement-mediated
hemolysis in PNH.
The other main type of compatibility test, the DAT, is typically used to diagnose causes of
hemolysis, such as transfusion-related
hemolysis, hemolytic disease of the fetus and newborn, autoimmune hemolytic anemia, and drug-induced immune
hemolysis.
Hemolysis During Hemodialysis: Etiology, Identification, Interventions, and Acute and Long-Term Sequalae
By blocking the amplification loop of the complement alternative pathway, ACH-4471 has the potential to control intravascular
hemolysis as well as prevent the development of extravascular
hemolysis," said Professor Peter Browett, BMedSci, MBChB, FRACP, FRCPA; Department of Molecular Medicine and Pathology, University of Auckland, Auckland, New Zealand.
It is approved in the US, European Union, Japan and other countries as the first and only treatment for patients with paroxysmal nocturnal hemoglobinuria to reduce
hemolysis.
A DAT can detect immunotargeting of transfused RBCs before
hemolysis is clinically evident, or it can confirm the presence of an alloantibody in suspected hemolytic transfusion reactions.
coagulase,
hemolysis [a (Hla), b, g (HLG), d], enterotoxins, toxic shock syndrome toxin (TST), exfoliatins and PVL) (Tomita and Kamio, 1997; Archer, 1998).
Unfortunately, there is a lack of data on streptococci for which true
hemolysis is very important for identification and other medically important human bacteria.
Beyond such regulatory requirements, a 2012 CLSI guideline provides a resource available to assay manufacturers regarding what specific information regarding
hemolysis might be published in an IFU (3).
Episodes of delayed
hemolysis 2-6 weeks after treatment for severe malaria with intravenous artesunate have been observed in non-malaria-immune patients in Europe (2).
The prevalence of a
hemolysis after PDA endocarditis is unknown.
It demonstrates plasma yield >40% from whole blood with little to no
hemolysis, an issue common among many fibrous substrates.
