Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

In this postmarketing study, the safety of Nonafact® (human coagulation factor IX) is evaluated in previous treated and untreated patients with severe, moderate or mild haemophilia B.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV

Criteria

Inclusion Criteria:

• Haemophilia B (mild, moderate or severe), Haemophilia B Leyden or symptomatic carriers of Haemophilia B and Haemophilia B Leyden

• Above the age of six, at the moment of inclusion

• Tested positive for HAV and HBV antibodies, induced by infection or vaccination, and negative for HBsAg

• Informed consent signed by the patients or his legally accepted representative

Exclusion Criteria:

• Under the age of six, at the moment of inclusion

• Tested negative for HAV and HBV antibodies