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)

Phase 2 Completed 48 enrolled Portola Pharmaceuticals

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2012-12
Primary completion: 2015-09
Completion: 2015-09

Outcome

Met primary endpoint

registry analysis (superiority test); Module 2 Placebo vs Module 2 (800 mg Bolus + 960 mg Infusion); p <0.0001; Least Squares Means (Difference) -231.12; ANCOVA NCT03578146 ↗

Publications

Lu G, Conley PB, Leeds JM, Karbarz MJ, Levy GG, Mathur VS, Castillo J, Crowther M, Curnutte JT. A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers. Blood Adv. 2020 Feb 25;4(4):728-739. doi: 10.1182/bloodadvances.2019000885.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andexanet alfa	Protein / enzyme biologic	210 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	240 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	420 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	600 mg	Intravenous
Subject	Andexanet alfa	Protein / enzyme biologic	960 mg	Intravenous
Background	Rivaroxaban	Other / unclassified	—	—

Indications

No indication recorded.