Project Title

BAX 855 PK-guided Dosing (PROPEL).

Official Title

Phase 3, Prospective, Randomized, Multi-center Clinical Study Comparing the Safety and Efficacy of BAX 855 Following PK-guided Prophylaxis Targeting Two Different FVIII Trough Levels in Subjects With Severe Hemophilia A.

Project Summary

This project aims to:

  1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%).
  2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855.

Blood Disorder

  • Hemophilia A

Patient Recruitment Details

Patient recruitment status: Closed

Number of Patients (globally)

135 participants.

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