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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00139828

Enrollment

Registered

2005-08-31

Start date

2003-05-31

Completion date

2007-02-28

Last updated

2007-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia B

Keywords

haemophilia B, factor IX, Product Surveillance, Postmarketing, plasma products

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'

Interventions

DRUGhuman coagulation Factor IX

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Occurrence of antibodies to factor IX	24 months

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026