Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
NCT00167973
Last updated date
ABOUT THIS STUDY
This 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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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
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Advanced Information
| Descriptive Information | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title | Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use | ||||||||||||||||||||||||
| Official Title | A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use | ||||||||||||||||||||||||
| Brief Summary | This 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 Description | Not Provided | ||||||||||||||||||||||||
| Study Type | Observational | ||||||||||||||||||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||||||||||
| Study Population | All EU patients beginning treatment with BeneFIX | ||||||||||||||||||||||||
| Condition | Hemophilia B | ||||||||||||||||||||||||
| Intervention | Not Provided | ||||||||||||||||||||||||
| Study Groups/Cohorts | Not 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 Status | Completed | ||||||||||||||||||||||||
| Actual Enrollment | 218 | ||||||||||||||||||||||||
| Original Enrollment | 175 | ||||||||||||||||||||||||
| Actual Study Completion Date | June 2009 | ||||||||||||||||||||||||
| Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: | ||||||||||||||||||||||||
| Sex/Gender |
| ||||||||||||||||||||||||
| Ages | Child, Adult, Older Adult | ||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
| Listed Location Countries | Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom | ||||||||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||
| NCT Number | NCT00167973 | ||||||||||||||||||||||||
| Other Study ID Numbers | 3090A-101039 | ||||||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||
| IPD Sharing Statement | Not Provided | ||||||||||||||||||||||||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||||||||||||||||||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||
| Collaborators | Not Provided | ||||||||||||||||||||||||
| Investigators |
| ||||||||||||||||||||||||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||
| Verification Date | May 2010 | ||||||||||||||||||||||||