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An HPA-1a–positive ...
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
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- Geisen, Christof (författare)
- German Red Cross Blood Service Baden-Württemberg – Hessen
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- Kjaer, Mette (författare)
- UiT The Arctic University of Norway, Tromsø
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- Fleck, Erika (författare)
- German Red Cross Blood Service Baden-Württemberg – Hessen
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- Skogen, Bjorn (författare)
- University Hospital of North Norway
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- Armstrong, Róisín (författare)
- Rallybio
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- Behrens, Frank (författare)
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
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- Bhagwagar, Zubin (författare)
- Rallybio
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- Braeuninger, Susanne (författare)
- German Red Cross Blood Service Baden-Württemberg – Hessen
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- Mortberg, Anette (författare)
- Karolinska Institutet,Karolinska Institute,Karolinska University Hospital
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Olsen, Klaus Juel (författare)
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Gastón Schäfer, Stephan Martin (författare)
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Walter, Carmen (författare)
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Seifried, Erhard (författare)
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- Wikman, Agneta (författare)
- Karolinska Institutet,Karolinska Institute,Karolinska University Hospital
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- Kjeldsen-Kragh, Jens (författare)
- Lund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Regional Laboratories Region Skåne,University Hospital of North Norway
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- Koehm, Michaela (författare)
- Fraunhofer Institute for Translational Medicine and Pharmacology ITMP
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(creator_code:org_t)
- Elsevier BV, 2023
- 2023
- Engelska 12 s.
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Ingår i: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 21:4, s. 838-849
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- 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 FNAIT. Objectives: To investigate whether a single dose of anti–HPA-1a (1000 IU) could markedly accelerate the elimination of HPA-1ab platelets transfused into healthy, HPA-1a–negative participants as compared with placebo. Methods: This randomized, single-blind, placebo–controlled, single-center, phase 1/2 proof-of-concept study (EudraCT: 2019-003459-12) included HPA-1a– and HLA-A2–negative healthy men. Cohort 1 received intravenous RLYB211 or placebo 1 hour after transfusion of HPA-1ab platelets. Cohort 1B received RLYB211 or placebo, followed by platelet transfusion 1 week later. Primary endpoint was the half-life of transfused platelets in circulation after administration of RLYB211 or placebo, determined by flow cytometry. Proof of concept was ≥90% reduction of half-life relative to placebo. Results: Twelve participants were allocated to cohort 1 or 1B and randomized to receive RLYB211 (n = 9) or placebo (n = 3). RLYB211 markedly accelerated the elimination of HPA-1ab platelets in all participants vs placebo. In cohort 1B, this effect was observed 7 days after RLYB211 administration. Two treatment–emergent adverse events were possibly related to treatment, both in RLYB211–treated participants. No participants developed HPA-1a antibodies at 12 or 24 weeks. Conclusion: These data support the hypothesis that anti–HPA-1a could be used as prophylaxis in women at risk of having an FNAIT–affected pregnancy.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Nyckelord
- alloantibodies
- human platelet antigen
- intracranial hemorrhage
- neonatal alloimmune thrombocytopenia
- prophylaxis
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- art (ämneskategori)
- ref (ämneskategori)
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- Av författaren/redakt...
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Geisen, Christof
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Kjaer, Mette
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Fleck, Erika
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Skogen, Bjorn
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Armstrong, Róisí ...
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Behrens, Frank
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Bhagwagar, Zubin
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Braeuninger, Sus ...
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Mortberg, Anette
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Olsen, Klaus Jue ...
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Gastón Schäfer, ...
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Walter, Carmen
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Seifried, Erhard
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Wikman, Agneta
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Kjeldsen-Kragh, ...
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Koehm, Michaela
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Hematologi
- Artiklar i publikationen
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Journal of Throm ...
- Av lärosätet
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Lunds universitet
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Karolinska Institutet