CLINICAL TRIALS PROFILE FOR ANDEXANET ALFA
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All Clinical Trials for andexanet alfa
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01758432 ↗ | Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4) | Completed | Portola Pharmaceuticals | Phase 2 | 2012-12-01 | The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses. |
| NCT03310021 ↗ | A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects | Completed | Portola Pharmaceuticals | Phase 2 | 2017-08-28 | "This is a single-center, randomized, double-blind, and placebo-controlled trial designed to: 1) demonstrate the degree to which administered andexanet doses can reverse Factor Ten A (FXa)-inhibitor induced anticoagulation; and 2) evaluate the safety and PK/PD of andexanet in healthy Japanese subjects taking direct FXa inhibitors at therapeutic doses." |
| NCT03330457 ↗ | A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing | Terminated | Portola Pharmaceuticals | Phase 2 | 2015-08-06 | This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban. |
| NCT03551730 ↗ | Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4) | Completed | Portola Pharmaceuticals | Phase 2 | 2012-12-01 | The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses. |
| NCT03551743 ↗ | Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4) | Completed | Portola Pharmaceuticals | Phase 2 | 2012-12-01 | The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses. |
| NCT03578146 ↗ | Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4) | Completed | Portola Pharmaceuticals | Phase 2 | 2012-12-01 | The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of several blood thinner drugs on laboratory tests. The study also is evaluating the blood levels of PRT064445 given at different doses. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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