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Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Vienna, , 1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for
Registry enrollment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00167973
Pfizer
Completed
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

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Descriptive Information
Brief TitleProspective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
Official TitleA Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
Brief SummaryThis is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationAll EU patients beginning treatment with BeneFIX
ConditionHemophilia B
InterventionNot Provided
Study Groups/CohortsNot Provided
Publications *Rendo P, Smith L, Lee HY, Shafer F. Nonacog alfa: an analysis of safety data from six prospective clinical studies in different patient populations with haemophilia B treated with different therapeutic modalities. Blood Coagul Fibrinolysis. 2015 Dec;26(8):912-8. doi: 10.1097/MBC.0000000000000359.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: May 25, 2010)
218
Original Enrollment
 (submitted: September 11, 2005)
175
Actual Study Completion DateJune 2009
Actual Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study:All
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesAustria,   Belgium,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00167973
Other Study ID Numbers3090A-101039
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial mANAGERFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Sweden, [email protected]
Principal Investigator:Trial ManagerFor Austria, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateMay 2010

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