NCT02764489

FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)

A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients With Hemophilia A or B With Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to: * 1\. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min * 2\. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume

Detailed description

15 JUN 2020: The temporary enrollment stop of new patients into this study due to the COVID-19 pandemic has been lifted in one or more countries/sites, and the study is now again enrolling new patients. However, some countries/sites may still have paused the enrollment of new patients due to the pandemic. 23 APRIL 2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Conditions

• Hemophilia A or B With Inhibitors

Interventions

Type	Name	Description
BIOLOGICAL	FEIBA	Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate \[APCC\]), FEIBA NF.

Timeline

• Start date: 2019-02-12
• Primary completion: 2021-12-27
• Completion: 2021-12-27
• First posted: 2016-05-06
• Last updated: 2023-02-14
• Results posted: 2023-02-09

Locations

3 sites across 3 countries: Croatia, North Macedonia, Ukraine

Regulatory

• FDA-regulated drug study