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

Phase 4

Completed

• Conditions: Hemophilia B
• Interventions: Drug: human coagulation Factor IX

• Registration Number: NCT00139828
• Lead Sponsor: Prothya Biosolutions

Brief 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'

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-08-31
• Study Completion: 2007-02
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-29
• Last Update Posted: 2007-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	human coagulation Factor IX	The amount of Nonafact® to be administered and the frequency of treatment is based on the SmPC and should always be determined on the basis of the clinical effectiveness in the individual patient

Primary Outcome Measures

Name	Time	Method
Number of bleeding episodes (efficacy after administration)	24 months
Haematological variables and clinical chemistry (safety)	24 months
Adverse events (safety)	24 months

Secondary Outcome Measures

Name	Time	Method
Occurrence of antibodies to factor IX	24 months

Trial Locations

Locations (7)

Erasmus Medical Centre; 🇳🇱 Rotterdam, Netherlands

Leyenburg Hospital; 🇳🇱 The Hague, Netherlands

Van Creveldkliniek; 🇳🇱 Utrecht, Netherlands

Academic Medical Centre; 🇳🇱 Amsterdam, Netherlands

LUMC; 🇳🇱 Leiden, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

UMC St. Radboud; 🇳🇱 Nijmegen, Netherlands