Study Evaluating Betrixaban in Pediatric Participants

Phase 1 Terminated 21 enrolled Alexion Pharmaceuticals, Inc. Portola Pharmaceuticals, LLC (a wholly owned subsidiary of Alexion Pharmaceuticals) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial was a Phase 1, open-label, multicenter study of the pharmacokinetics (PK), pharmacodynamics (PD), and safety of a single dose of betrixaban in pediatric participants at risk of venous thromboembolism (VTE).

Timeline

Start: 2018-07-13
Primary completion: 2019-10-08
Completion: 2019-10-08

Outcome

Outcome not reported

Stopped: “After completion of Part 1 and prior to initiating Part 2, the Sponsor decided to cease developing betrixaban, prompting early study closure.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Betrixaban	Small molecule	40 mg	Oral
Subject	Betrixaban	Small molecule	80 mg	Oral

Indications

No indication recorded.