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NCT00139828 Clinical Trial

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

Hemophilia B Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00139828
Other study ID # KB2000.03
Secondary ID
Status Completed
Phase Phase 4
First received August 30, 2005
Last updated August 29, 2007
Start date May 2003
Est. completion date February 2007

Study information
Verified date August 2007
Source Sanquin
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

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'

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• human coagulation Factor IX

Locations
Country Name City State
Netherlands Academic Medical Centre Amsterdam
Netherlands Kennemer Gasthuis Haarlem
Netherlands LUMC Leiden
Netherlands UMC St. Radboud Nijmegen
Netherlands Erasmus Medical Centre Rotterdam
Netherlands Leyenburg Hospital The Hague
Netherlands Van Creveldkliniek Utrecht

Sponsors (1)
Lead Sponsor Collaborator
Sanquin

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of bleeding episodes (efficacy after administration) 24 months
Primary Haematological variables and clinical chemistry (safety) 24 months
Primary Adverse events (safety) 24 months
Secondary Occurrence of antibodies to factor IX 24 months
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