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 | 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at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive | Withdrawn | Biotest Pharmaceuticals Corporation | N/A | 2009-09-25 | This is a prospective, controlled, randomized, open label study, aimed at comparing FVIII/VWF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 | Withdrawn | Charta Fondazione | N/A | 2009-09-25 | 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 | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for KOGENATE FS
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Clinical Trial Progress for KOGENATE FS
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