scholarly journals SHP656, a polysialylated recombinant factor VIII (PSA‐rFVIII): First‐in‐human study evaluating safety, tolerability and pharmacokinetics in patients with severe haemophilia A

Haemophilia ◽  
2019 ◽  
Vol 26 (1) ◽  
pp. 47-55 ◽  
Author(s):  
Andreas Tiede ◽  
Geoffrey Allen ◽  
Alexander Bauer ◽  
Pratima Chowdary ◽  
Peter Collins ◽  
...  
Keyword(s):  
Factor Viii ◽  
Human Study ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia

Safety and efficacy of sucrose-formulated full-length recombinant factor VIII: Experience in the standard clinical setting

2008 ◽  
Vol 99 (01) ◽  
pp. 52-58 ◽  
Author(s):  
Elena Santagostino ◽  
Albert Faradji ◽  
Alfonso Iorio ◽  
Jan van der Meer ◽  
Jørgen Ingerslev ◽  
...  
Keyword(s):  
Observational Study ◽  
Factor Viii ◽  
De Novo ◽  
Observation Time ◽  
Full Length ◽  
Recombinant Factor Viii ◽  
Phase Iii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Safety And Efficacy

SummaryThe safety of full-length sucrose-formulated recombinant factor VIII (rFVIII-FS; KOGENATE® FS) for up to 24 months of use was evaluated in a postmarketing observational study in Europe. Long-term safety and efficacy data were available for 212 patients with severe haemophilia A, including 13 previously untreated patients (PUPs) and 12 patients with 1–19 exposure days (EDs). Patients accumulated a mean (± SD) of 187 (121) EDs to rFVIII-FS and received a total of 39,627 infusions, mainly for prophylaxis and for the treatment of 4,283 spontaneous or trauma-related bleeds during an average observation time of 710 (136) days. Of these bleeding episodes, 85.4% were successfully treated with one or two infusions of rFVIII-FS. Haemostasis was also evaluated during 46 minor to major surgical pro- cedures, and the response to infusion was “excellent” or “good” in all cases. FVIII inhibitor formation was observed in six patients (two de novo; four persistent or recurrent). The de novo cases represent 8.0% (2 of 25) of patients who reported 0–19 previous EDs at study entry. Four of the five patients who reported possible drug-related adverse effects developed inhibitors. The results of this observational study demonstrate the efficacy and safety of rFVIII-FS during normal clinical use in the treatment of patients with severe haemophilia A. Furthermore, these findings are consistent with those of previous phase III clinical studies with rFVIII-FS, particularly with regard to its efficacy and low incidence of inhibitor formation.

scholarly journals Recombinant factor VIII Fc fusion protein for immune tolerance induction in patients with severe haemophilia A with inhibitors-A retrospective analysis

Haemophilia ◽  
2018 ◽  
Vol 24 (2) ◽  
pp. 245-252 ◽  
Author(s):  
M. Carcao ◽  
A. Shapiro ◽  
J. M. Staber ◽  
N. Hwang ◽  
C. Druzgal ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Factor Viii ◽  
Retrospective Analysis ◽  
Immune Tolerance ◽  
Tolerance Induction ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Immune Tolerance Induction ◽  
Fc Fusion Protein

scholarly journals PROTECT VIII Kids: BAY 94‐9027 (PEGylated Recombinant Factor VIII) safety and efficacy in previously treated children with severe haemophilia A

Haemophilia ◽  
2020 ◽  
Vol 26 (3) ◽  
Author(s):  
Elena Santagostino ◽  
Gili Kenet ◽  
Kathelijn Fischer ◽  
Tina Biss ◽  
Sanjay Ahuja ◽  
...  
Keyword(s):  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Safety And Efficacy ◽  
Previously Treated

IgE-mediated anaphylactic reaction to purified and recombinant factor VIII in a patient with severe haemophilia A

Haemophilia ◽  
2007 ◽  
Vol 13 (1) ◽  
pp. 104-105 ◽  
Author(s):  
J. G. KADAR ◽  
J. SCHUSTER ◽  
N. HUNZELMANN
Keyword(s):  
Factor Viii ◽  
Anaphylactic Reaction ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Ige Mediated

scholarly journals Once‐weekly prophylaxis with glycoPEGylated recombinant factor VIII (N8‐GP) in severe haemophilia A: Safety and efficacy results from pathfinder 2 (randomized phase III trial)

Haemophilia ◽  
2019 ◽  
Vol 25 (3) ◽  
pp. 373-381 ◽  
Author(s):  
Nicola Curry ◽  
Canan Albayrak ◽  
Miguel Escobar ◽  
Pål Andre Holme ◽  
Susan Kearney ◽  
...  
Keyword(s):  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Phase Iii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Phase Iii Trial ◽  
Safety And Efficacy

Recombinant factor VIII products and inhibitor development in previously untreated patients with severe haemophilia A: Combined analysis of three studies

Haemophilia ◽  
2019 ◽  
Vol 25 (3) ◽  
pp. 398-407 ◽  
Author(s):  
Peter Volkers ◽  
Kay‐Martin Hanschmann ◽  
Thierry Calvez ◽  
Hervé Chambost ◽  
Peter W. Collins ◽  
...  
Keyword(s):  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Combined Analysis ◽  
Inhibitor Development

Continuous infusion of recombinant factor VIII formulated with sucrose in surgery: Non-interventional, observational study in patients with severe haemophilia A

Haemophilia ◽  
2014 ◽  
Vol 21 (1) ◽  
pp. e19-e25 ◽  
Author(s):  
K. Meijer ◽  
S. Rauchensteiner ◽  
E. Santagostino ◽  
H. Platokouki ◽  
R. E. G. Schutgens ◽  
...  
Keyword(s):  
Observational Study ◽  
Factor Viii ◽  
Continuous Infusion ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia

The safety and efficacy of B-domain deleted recombinant factor VIII concentrate in patients with severe haemophilia A

Haemophilia ◽  
2003 ◽  
Vol 9 (1) ◽  
pp. 38-49 ◽  
Author(s):  
J. M. Lusher ◽  
C. A. Lee ◽  
C. M. Kessler ◽  
C. L. Bedrosian ◽  
Keyword(s):  
Factor Viii ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia ◽  
Safety And Efficacy

Efficacy of a sucrose-formulated recombinant factor VIII used for 22 surgical procedures in patients with severe haemophilia A

Haemophilia ◽  
2000 ◽  
Vol 6 (6) ◽  
pp. 614-618 ◽  
Author(s):  
I. Scharrer ◽  
H.-H. Brackmann ◽  
Y. Sultan ◽  
T. Abshire ◽  
C. Gazengel ◽  
...  
Keyword(s):  
Factor Viii ◽  
Surgical Procedures ◽  
Recombinant Factor Viii ◽  
Haemophilia A ◽  
Severe Haemophilia
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