CLINICAL TRIALS PROFILE FOR ADVATE
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All Clinical Trials for ADVATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00168051 ↗ | Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A | Withdrawn | Wyeth is now a wholly owned subsidiary of Pfizer | Phase 4 | 2005-04-01 | The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma. |
| NCT00189982 ↗ | Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101 | Completed | Baxalta now part of Shire | Phase 2/Phase 3 | 2004-12-17 | The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101. |
| NCT00189982 ↗ | Efficacy and Safety Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients in Canada With Hemophilia A - A Continuation of Baxter Study 060101 | Completed | Baxalta US Inc. | Phase 2/Phase 3 | 2004-12-17 | The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of children with hemophilia A. The study is open to pediatric patients in Canada who completed Baxter Study 060101. |
| NCT00214734 ↗ | ADVATE Post Authorization Safety Surveillance | Completed | Baxter BioScience | 2004-10-14 | The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice. | |
| NCT00214734 ↗ | ADVATE Post Authorization Safety Surveillance | Completed | Baxalta now part of Shire | 2004-10-14 | The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice. | |
| NCT00214734 ↗ | ADVATE Post Authorization Safety Surveillance | Completed | Baxalta US Inc. | 2004-10-14 | The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice. | |
| NCT00243386 ↗ | Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A | Completed | Baxalta now part of Shire | Phase 4 | 2006-01-04 | The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient's pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for ADVATE
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Clinical Trial Locations for ADVATE
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Clinical Trial Progress for ADVATE
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Clinical Trial Sponsors for ADVATE
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