Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00714415
First received: July 8, 2008
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia B |
Drug: BeneFIX |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Pharmacovigilance Evaluation Of BeneFIX |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
Drug Information available for:
Factor IX
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Reporting of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Efficacy in controlling bleeding [ Time Frame: 36 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
Patients with Hemophilia B
|
Drug: BeneFIX
Patients will be treated in accordance with the requirements of the labeling of BeneFIX in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
|
Detailed Description:
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with hemophilia B
Criteria
Inclusion Criteria:
- Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®.
Exclusion Criteria:
- Patients with hemophilia B treated with a product other than BeneFIX®.
- Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00714415
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Austria | |
| Pfizer Investigational Site | Recruiting |
| Linz, Austria, 4020 | |
| Germany | |
| Pfizer Investigational Site | Recruiting |
| Muenster, Nordrhein-Westfalen, Germany, 48143 | |
| Pfizer Investigational Site | Recruiting |
| Berlin, Germany, 13353 | |
| Pfizer Investigational Site | Recruiting |
| Blaubeuren, Germany, 89143 | |
| Pfizer Investigational Site | Recruiting |
| Bonn, Germany, 53127 | |
| Pfizer Investigational Site | Recruiting |
| Brannenburg, Germany, 83098 | |
| Pfizer Investigational Site | Recruiting |
| Bremen, Germany, 28177 | |
| Pfizer Investigational Site | Recruiting |
| Delmenhorst, Germany, 27753 | |
| Pfizer Investigational Site | Recruiting |
| Duesseldorf, Germany, 40225 | |
| Pfizer Investigational Site | Recruiting |
| Duisburg, Germany, 47051 | |
| Pfizer Investigational Site | Recruiting |
| Halle, Germany, 06120 | |
| Pfizer Investigational Site | Recruiting |
| Hamburg, Germany, 20251 | |
| Pfizer Investigational Site | Recruiting |
| Hamburg, Germany, 20246 | |
| Pfizer Investigational Site | Recruiting |
| Heidelberg, Germany, 69123 | |
| Pfizer Investigational Site | Recruiting |
| Koeln, Germany, 50677 | |
| Pfizer Investigational Site | Recruiting |
| Memmingen, Germany, 87700 | |
| Pfizer Investigational Site | Recruiting |
| Muenchen, Germany, 80337 | |
| Pfizer Investigational Site | Recruiting |
| Tuebingen, Germany, 72076 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00714415 History of Changes |
| Other Study ID Numbers: | 3090A1-4406, B1821011 |
| Study First Received: | July 8, 2008 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Germany: Paul-Ehrlich-Institut |
Additional relevant MeSH terms:
|
Hemophilia B Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases |
Coagulation Protein Disorders Hemorrhagic Disorders Genetic Diseases, Inborn Genetic Diseases, X-Linked |
ClinicalTrials.gov processed this record on May 16, 2013