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

This study has been completed.
Sponsor:
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00139828
First received: August 30, 2005
Last updated: August 29, 2007
Last verified: August 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemophilia B
 Drug: human coagulation Factor IX
 Phase 4

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

Resource links provided by NLM:

Drug Information available for: Factor IX
U.S. FDA Resources

Further study details as provided by Sanquin:

Primary Outcome Measures:
  • Number of bleeding episodes (efficacy after administration) [ Time Frame: 24 months ]
  • Haematological variables and clinical chemistry (safety) [ Time Frame: 24 months ]
  • Adverse events (safety) [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Occurrence of antibodies to factor IX [ Time Frame: 24 months ]

Enrollment: 12
Study Start Date: May 2003
Study Completion Date: February 2007
Arms Assigned Interventions
A
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
 Drug: human coagulation Factor IX
Other Name: Nonafact

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'

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139828

Locations
Netherlands
Academic Medical Centre
Amsterdam, Netherlands, 1105 AZ
Kennemer Gasthuis
Haarlem, Netherlands
LUMC
Leiden, Netherlands, 2333 ZA
UMC St. Radboud
Nijmegen, Netherlands, 6525 GA
Erasmus Medical Centre
Rotterdam, Netherlands, 3015 GD
Leyenburg Hospital
The Hague, Netherlands, 2545 CH
Van Creveldkliniek
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
Sanquin
Investigators
Principal Investigator: E P Mauser-Bunschoten, MD, PdD UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00139828     History of Changes
Other Study ID Numbers: KB2000.03
Study First Received: August 30, 2005
Last Updated: August 29, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sanquin:
haemophilia B
factor IX
Product Surveillance, Postmarketing
plasma products

Additional relevant MeSH terms:
Hemophilia B
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on May 23, 2013