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Last Updated: September 28, 2020

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CLINICAL TRIALS PROFILE FOR KOGENATE FS

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All Clinical Trials for KOGENATE FS

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00245297 Study of the Efficacy of Human Recombinant Factor VIII (Kogenate FS) Reconstituted in Pegylated Liposomes. Completed Recoly N.V. Phase 2 2005-10-01 Primary efficacy endpoint: To study whether there is a difference in the length of the bleeding free periods between infusion of FVIII that is reconstituted with 22.1, 12.6, or 4.2 mg of pegylated liposomes per kg bwt compared with standard formulation. Safety endpoint: To study the safety and tolerability of Kogenate FS reconstituted with Pegylated liposomes
NCT00621673 Assessment of the Risk of Inhibitor Formation in Previously Treated Patients With Severe Hemophilia A Terminated Bayer Phase 4 2006-05-01 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.
NCT00632814 Russian Kogenate Pediatric Study Completed Bayer Phase 4 2007-06-01 A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
NCT00864552 International PMS Study - KOGENATE Bayer Completed Bayer N/A 2002-12-01 To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
NCT01051544 Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive Active, not recruiting Biotest Pharmaceuticals Corporation N/A 2009-06-01 This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for success.
NCT01051544 Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive Active, not recruiting Charta Fondazione N/A 2009-06-01 This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF concentrates with FVIII concentrates at 200 IU/kg daily in their ability to induce immune tolerance in Haemophilia A patients with high responding inhibitors and poor prognosis for success.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KOGENATE FS

Condition Name

Condition Name for KOGENATE FS
Intervention Trials
Hemophilia A 5
Severe Hemophilia A 1
Haemophilia A 1
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Condition MeSH

Condition MeSH for KOGENATE FS
Intervention Trials
Hemophilia A 7
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Clinical Trial Locations for KOGENATE FS

Trials by Country

Trials by Country for KOGENATE FS
Location Trials
United States 3
Russian Federation 2
Italy 2
Switzerland 1
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Trials by US State

Trials by US State for KOGENATE FS
Location Trials
California 1
Nevada 1
Michigan 1
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Clinical Trial Progress for KOGENATE FS

Clinical Trial Phase

Clinical Trial Phase for KOGENATE FS
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
N/A 4
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Clinical Trial Status

Clinical Trial Status for KOGENATE FS
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for KOGENATE FS

Sponsor Name

Sponsor Name for KOGENATE FS
Sponsor Trials
Bayer 5
CSL Behring 1
Charta Fondazione 1
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Sponsor Type

Sponsor Type for KOGENATE FS
Sponsor Trials
Industry 10
Other 2
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