Back to resultsPost Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
Primary Purpose
Hemophilia B
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
human coagulation Factor IX
Sponsored by
About this trial
This is an interventional treatment trial for Hemophilia B focused on measuring haemophilia B, factor IX, Product Surveillance, Postmarketing, plasma products
Eligibility 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
Sites / Locations
- Academic Medical Centre
- Kennemer Gasthuis
- LUMC
- UMC St. Radboud
- Erasmus Medical Centre
- Leyenburg Hospital
- Van Creveldkliniek
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm 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
Outcomes
Primary Outcome Measures
Number of bleeding episodes (efficacy after administration)
Haematological variables and clinical chemistry (safety)
Adverse events (safety)
Secondary Outcome Measures
Occurrence of antibodies to factor IX
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00139828
Brief Title
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Prothya Biosolutions
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia B
Keywords
haemophilia B, factor IX, Product Surveillance, Postmarketing, plasma products
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm 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
Intervention Type
Drug
Intervention Name(s)
human coagulation Factor IX
Other Intervention Name(s)
Nonafact
Primary Outcome Measure Information:
Title
Number of bleeding episodes (efficacy after administration)
Time Frame
24 months
Title
Haematological variables and clinical chemistry (safety)
Time Frame
24 months
Title
Adverse events (safety)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Occurrence of antibodies to factor IX
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
E P Mauser-Bunschoten, MD, PdD
Organizational Affiliation
UMC Utrecht, Van Creveldkliniek, Utrecht, The Netherlands
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Centre
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
Country
Netherlands
Facility Name
LUMC
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus Medical Centre
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Leyenburg Hospital
City
The Hague
ZIP/Postal Code
2545 CH
Country
Netherlands
Facility Name
Van Creveldkliniek
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Post Marketing Study in Haemophilia B Patients Using Nonafact® (Human Coagulation Factor IX)
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