NCT00139828

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

Post Marketing Study in Haemophilia B Patients Using Nonafact® 100 IU/ml Powder and Solvent for Solution for Injection(Human Coagulation Factor IX)(Human Plasma Derived Factor IX Product, Freeze Dried)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Prothya Biosolutions · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical efficacy and safety of Nonafact® has been shown in two pre-authorisation studies. Marketing authorisation for the EU was granted 3 July 2001. The Post Marketing Study, which evaluates the clinical efficacy, immunogenicity and safety of Nonafact®, is set up according to CPMP/BPWG /198/95, rev. 1 (Final, London, 19 October 2000) 'Note for guidance on the clinical investigation of human plasma derived factor VIII and IX products'

Conditions

• Hemophilia B

Interventions

Type	Name	Description
DRUG	human coagulation Factor IX

Timeline

• Start date: 2003-05-01
• Completion: 2007-02-01
• First posted: 2005-08-31
• Last updated: 2007-08-30

Locations

7 sites across 1 country: Netherlands