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

Prothya Biosolutions

Status and phase: Completed; Phase 4

Conditions: Hemophilia B

Treatments: Drug: human coagulation Factor IX

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139828

KB2000.03

Details and patient eligibility

About

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.

Full 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'

Enrollment: 12 patients

Sex: All

Ages: 6+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

A

Other group

Description:

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

Treatment:

Drug: human coagulation Factor IX