SHP656, a polysialylated recombinant factor VIII (PSA‐rFVIII): First‐in‐human study evaluating safety, tolerability and pharmacokinetics in patients with severe haemophilia A
| العنوان: | SHP656, a polysialylated recombinant factor VIII (PSA‐rFVIII): First‐in‐human study evaluating safety, tolerability and pharmacokinetics in patients with severe haemophilia A |
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| المؤلفون: | Andreas Tiede, Pratima Chowdary, Margarita Timofeeva, Geoffrey Allen, Kathleen Kӧck, Martin J. Wolfsegger, Alexander Bauer, Hongyu Jeanne Jiang, Peter William Collins, Brahm Goldstein, István Takács, Shouryadeep Srivastava |
| المصدر: | Haemophilia |
| بيانات النشر: | Wiley, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | safety, Adult, medicine.medical_specialty, polysialic acid, haemophilia A, 030204 cardiovascular system & hematology, Hemophilia A, Recombinant factor viii, Gastroenterology, 03 medical and health sciences, recombinant FVIII, 0302 clinical medicine, Pharmacokinetics, Internal medicine, medicine, Humans, In patient, tolerability, Clinical Haemophilia, Adverse effect, Genetics (clinical), Factor VIII, biology, business.industry, Immunogenicity, Original Articles, Hematology, General Medicine, Recombinant Proteins, Cohort, Sialic Acids, biology.protein, Original Article, Severe haemophilia A, Antibody, business, pharmacokinetics, 030215 immunology |
| الوصف: | Introduction SHP656 is the first factor VIII (FVIII) product developed using polysialylation (PSA) technology, in which full‐length recombinant (r) FVIII (anti‐haemophilic factor [recombinant]) is conjugated with a 20 kDa PSA polymer. Aim To compare the safety, immunogenicity and pharmacokinetics of SHP656 vs the parent rFVIII (octocog alfa) after single infusions of 25‐75 IU/kg in patients with severe haemophilia A (FVIII activity |
| وصف الملف: | application/pdf |
| تدمد: | 1365-2516 1351-8216 0271-6194 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d90ff18203cf96bc8686d8b819eedb6d https://doi.org/10.1111/hae.13878 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....d90ff18203cf96bc8686d8b819eedb6d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 13652516 13518216 02716194 |
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