KOATE-DVI SUMMARY
Antihemophilic Factor (Human), Koà te®-DVI, is a sterile, stable, purified, dried concentrate of human Antihemophilic Factor (AHF, factor VIII, AHG) which has been treated with tri-n-butyl phosphate (TNBP) and polysorbate 80 and heated in lyophilized form in the final container at 80°C for 72 hours. Koà te-DVI is intended for use in therapy of classical hemophilia (hemophilia A).
Koà te-DVI is indicated for the treatment of classical hemophilia (hemophilia A) in which there is a demonstrated deficiency of activity of the plasma clotting factor, factor VIII. Koà te-DVI provides a means of temporarily replacing the missing clotting factor in order to control or prevent bleeding episodes, or in order to perform emergency and elective surgery on individuals with hemophilia.
Koà te-DVI contains naturally occurring von Willebrand's factor, which is co-purified as part of the manufacturing process.
Koà te-DVI has not been investigated for efficacy in the treatment of von Willebrand's disease, and hence is not approved for such usage.
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NEWS HIGHLIGHTS
Published Studies Related to Koate-DVI (Antihemophilic Factor)
Sucrose formulated recombinant human antihemophilic factor VIII is safe and efficacious for treatment of hemophilia A in home therapy--International Kogenate-FS Study Group. [2000.06]
To add an increased level of safety to antihemophilic factor replacement therapy, a full-length, recombinant Factor VIII (rFVIII) product has been developed without human-derived plasma proteins during purification and formulation and using an additional solvent/detergent viral inactivation step...
Clinical Trials Related to Koate-DVI (Antihemophilic Factor)
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A [Completed]
The study will consist of two parts: a safety and efficacy period in which all subjects will
participate and a pharmacokinetic analysis period, in which 30 eligible subjects will
participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of
ReFacto AF in patients with Hemophilia A.
Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A [Terminated]
Most transient inhibitor formation, if any, will develop within the first 4 weeks. The study
is to further monitor whether participants with severe Hemophilia A will develop inhibitors
or antibodies at the later stage when switched from their current recombinant therapy
produced from Chinese Hamster Ovary (CHO) cell line to Kogenate®-FS raised in a Baby Hamster
Kidney cell line.
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A [Active, not recruiting]
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial
recovery (% increase [IU/dL] per IU/kg infused) and major single-infusion pharmacokinetic
parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not
have received treatment with a factor VIII concentrate for at least 3 days. Blood samples
will be drawn within 30 minutes pre-infusion and at 0. 25, 0. 5, 1, 3, 6, 9, 24, 28, 32 and 48
hours post-infusion. A washout period of at least 3 days, but no more than 30 days between
the last blood draw and the next infusion will be observed. During participation, subjects
will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII
concentrate.
A secondary objective is to investigate the relationship between pharmacokinetic parameters
at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and
von Willebrand factor antigen at baseline.
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings [Recruiting]
The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and
other Factor VIII products.
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A [Completed]
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Page last updated: 2006-01-31
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