NCT00884390

Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings

A Postauthorization Safety Surveillance Study Of Patients Switching To ReFacto AF From ReFacto Or Other Factor VIII Products In Usual Care Settings

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The study will be investigating safety in patients who switch to ReFacto AF from ReFacto and other Factor VIII products.

Detailed description

The trial was terminated prematurely on 28 March 2013, due to the inability to recruit the planned number of subjects. The decision to terminate the trial was not based on any safety or efficacy concerns and agreement to close the study in March 2013 was agreed with EMA prior to closure activity.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
DRUG	moroctocog alfa (AF-CC) (ReFacto AF)	Providing moroctocog alfa (AF-CC) as test article for use during this study.
PROCEDURE	Laboratory tests	Laboratory samples are collected during study visits, in order to collect safety and efficacy data related to the administration of test article.

Timeline

• Start date: 2009-05-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-04-20
• Last updated: 2014-09-01
• Results posted: 2014-09-01

Locations

74 sites across 14 countries: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Romania, Spain, Sweden, United Kingdom