NCT00759655

Study Evaluating The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age

An Open-Label Study To Evaluate The Efficacy And Safety Of Xyntha In Children Less Than 6 Years Of Age In Usual Care Settings

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: Male
• Age: 0 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver assessments of responses to treatment will be characterized. FVIII inhibitor levels will be assessed throughout the study.

Detailed description

The study was terminated on 22 Sept 2009 due to competition with another Wyeth study for a similar patient population. The decision to terminate the trial was not based on any safety issues.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	Moroctocog alfa	Patients will receive Moroctocog alfa according to their investigator's prescription.

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-09-25
• Last updated: 2022-06-15
• Results posted: 2011-01-04