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

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ClinicalTrials.gov Identifier: NCT00139828
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 30, 2007
Sponsor:
Information provided by:
Sanquin Plasma Products BV

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.

Condition or disease Intervention/treatment Phase
Hemophilia B Drug: human coagulation Factor IX Phase 4

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'

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : May 2003
Actual Study Completion Date : February 2007


Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139828


Locations
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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 Plasma Products BV
Investigators
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Principal Investigator: E P Mauser-Bunschoten, MD, PdD UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands

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ClinicalTrials.gov Identifier: NCT00139828     History of Changes
Other Study ID Numbers: KB2000.03
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 30, 2007
Last Verified: August 2007
Keywords provided by Sanquin Plasma Products BV:
haemophilia B
factor IX
Product Surveillance, Postmarketing
plasma products
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked