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Kovaltry

Manufactured by Bayer
Sourced in United States

Kovaltry is a coagulation factor VIII product used for the treatment and prevention of bleeding episodes in patients with hemophilia A. It serves as a replacement for the missing or deficient factor VIII protein in the blood, which is necessary for proper blood clotting.

Automatically generated - may contain errors

2 protocols using kovaltry

1

Comparative Study of FVIII and VWF-FVIII Products

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Plasma-derived VWF-FVIII (2.4:1, Humate-P) was from CSL Behring (King of Prussia, USA), and (1:1, Wilate) was from Octapharma, Lachen, Switzerland. Human recombinant FVIII (rFVIII) products included Advate (Baxter, Deerfield, USA), Kogenate-FS and Kovaltry (Bayer, Leverkusen, Germany), Xyntha (Pfizer, New York, USA), and Nuwiq (Octapharma). Plasma-derived FVIII (pdFVIII) (Haemocetin) (Biotest, Dreieich, Germay) had been purified to contain 1% VWF. All experiments unless otherwise specified were performed with Advate (rFVIII) or Humate P (pdVWF-FVIII).
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2

Pharmacokinetic Comparison of BAY 81-8973 and rAHF-PFM

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This was a phase I, single-dose, open-label, randomized, crossover study to compare the PK of BAY 81-8973 with rAHF-PFM (ClinicalTrials.gov identifier: NCT02483208). Patients (N = 18) were randomized according to a computer-generated randomization list to receive a single infusion of 50 IU/kg BAY 81-8973 (Kovaltry®; Bayer, Berkeley, CA, USA) or 50 IU/kg rAHF-PFM (Advate®; Baxalta, Westlake Village, CA, USA), followed by crossover to a single infusion of the other treatment, with washout periods of ≥3 days before each single dose. Both products were administered as 10-min intravenous infusions. Informed consent was provided by the patients, and the protocol was approved by the site’s independent Ethics Committee/Institutional Review Board.
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