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Hemophilia |
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Clinical Trial: Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
This study is no longer recruiting patients.
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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 IV |
MedlinePlus related topics: Bleeding Disorders; Blood and Blood Disorders; Genetic Disorders
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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)
Further Study Details:
Primary Outcomes: Number of bleeding episodes (efficacy after administration); Haematological variables and clinical chemistry (safety); Adverse events (safety)
Secondary Outcomes: Occurrence of antibodies to factor IX
Expected Total Enrollment: 30
Secondary Outcomes: Occurrence of antibodies to factor IX
Expected Total Enrollment: 30
Study start: May 2003; Study completion: April 2007
Last follow-up: January 2007; Data entry closure: March 2007
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 above, Genders Eligible for Study: Both
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
Location Information
Netherlands
Leyenburg Hospital, The Hague, 2545 CH, Netherlands
LUMC, Leiden, 2333 ZA, Netherlands
UMC St. Radboud, Nijmegen, 6525 GA, Netherlands
Academic Medical Centre, Amsterdam, 1105 AZ, Netherlands
Erasmus Medical Centre, Rotterdam, 3015 GD, Netherlands
Kennemer Gasthuis, Haarlem, Netherlands
Van Creveldkliniek, Utrecht, 3584CX, Netherlands
Study chairs or principal investigators
E P Mauser-Bunschoten, MD, PdD, Principal Investigator, UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
More Information
Study ID Numbers: KB2000.03
Last Updated: August 30, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00139828
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: August 30, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00139828
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Bleeding Disorders (National Women's Health Information Center)
- Bleeding Disorders: Financial and Insurance Issues (National Hemophilia Foundation)
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