Blar i forfatter "Fleck, Erika"

Viser treff 1-2 av 2

    • An HPA-1a-positive platelet-depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo-controlled, single-center, phase 1/2 proof-of-concept study 

      Geisen, Christof; Kjær, Mette; Fleck, Erika; Skogen, Bjørn; Armstrong, Roisin; Behrens, Frank; Bhagwagar, Zubin; Braeuninger, Susanne; Mörtberg, Anette; Olsen, Klaus Juel; Scafer, Stephan Martin Gaston; Walter, Carmen; Seifried, Erhard; Wikman, Agneta; Kjeldsen-Kragh, Jens; Koehm, Michaela (Journal article; Tidsskriftartikkel; Peer reviewed, 2022-12-22)
      Background: Fetal/neonatal alloimmune thrombocytopenia (FNAIT) is a rare and potentially life-threatening bleeding disorder of the fetus/newborn. Antibodies against human platelet antigen 1a (HPA-1a) are associated with the most frequent FNAIT cases. There are no approved therapies for FNAIT prevention or treatment. RLYB211 is a polyclonal HPA-1a hyperimmune IgG being developed to prevent ...

    • A Phase 1b PK/PD Study to Demonstrate Antigen Elimination with RLYB212, a Monoclonal Anti-HPA-1a Antibody for FNAIT Prevention 

      Geisen, Christof; Fleck, Erika; Schäfer, Stephan Martin Gastón; Walter, Carmen; Braeuninger, Susanne; Jensen, Jens Søndergaard; Sheridan, Douglas; Patki, Kiran; Armstrong, Róisín; Skogen, Bjørn; Behrens, Frank; Seifried, Erhard; Kjeldsen-Kragh, Jens; Kjær, Mette; Köhm, Michaela (Journal article; Tidsskriftartikkel; Peer reviewed, 2024-09-12)
      Background - Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is a rare bleeding disorder of the fetus/newborn caused by development of maternal alloantibodies against fetal human platelet antigens (HPAs), predominantly HPA-1a. Currently there are no treatments available to prevent maternal alloimmunization to HPAs or FNAIT.<p> <p>Methods - This proof-of-concept study (EudraCT Number: ...