Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Observation for safety | Study Duration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All EU patients beginning treatment with BeneFIX
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial mANAGER | For Germany, MedInfoDEU@wyeth.com | Principal Investigator |
| Trial Manager | For Italy, descresg@wyeth.com | Principal Investigator |
| Trial Manager | For Belgium, trials-BEL@wyeth.com | Principal Investigator |
| Trial Manager | For Netherlands, trials-NL@wyeth.com | Principal Investigator |
| Trial Manager | For Sweden, MedInfoNord@wyeth.com | Principal Investigator |
| Trial Manager | For Austria, WPVIMED@wyeth.com | Principal Investigator |
| Trial Manager | For UK, ukmedinfo@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | 1090 | Austria | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26196195 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brussels |
| 1020 |
| Belgium |
| Brussels | 1090 | Belgium |
| Brussels | 1200 | Belgium |
| Edegem | 2650 | Belgium |
| Leuven | 3000 | Belgium |
| Montegnée | 4420 | Belgium |
| Amiens | 80 80054 | France |
| Angers | 49 49033 | France |
| Caen | 14 14033 | France |
| Chambéry | 73 73011 | France |
| Grenoble | 38 38043 | France |
| Le Chesnay | 78 78153 | France |
| Le Kremlin-Bicêtre | 94 94279 | France |
| Liffré | 35 35340 | France |
| Limoges | 87 87042 | France |
| Lyon | 03 69437 | France |
| Lyon | 69 69000 | France |
| Marseille | 13 13385 | France |
| Montmorency | 95 95160 | France |
| Montpellier | 34 34059 | France |
| Montpellier | 34 34295 | France |
| Nantes | 44 44093 | France |
| Nevers | 58 58020 | France |
| Nice | 06 06202 | France |
| Osséja | 66 66344 | France |
| Paris | 75 75674 | France |
| Paris | 75 75743 | France |
| Rouen | 76 76031 | France |
| Saint-Priest-en-Jarez | 42 42270 | France |
| Tours | 37 37044 | France |
| Erlangen | Bavaria | 91054 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Münster | North Rhine-Westphalia | 48143 | Germany |
| Ancona | AN | 60100 | Italy |
| Bari | BA | 70124 | Italy |
| Catania | CT | 95124 | Italy |
| Catanzaro | CZ | 88100 | Italy |
| Milan | MI | 20162 | Italy |
| Palermo | PA | 90134 | Italy |
| Pescara | PE | 65100 | Italy |
| Parma | PR | 43100 | Italy |
| Reggio Calabria | RC | 89100 | Italy |
| Sassari | SS | 07100 | Italy |
| Naples | 80131 | Italy |
| Padova | Italy |
| Palermo | 90100 | Italy |
| Perugia | 06126 | Italy |
| Roma | 00161 | Italy |
| Vicenza | 36100 | Italy |
| Amsterdam | 1007 MB | Netherlands |
| Breda | 4818 CK | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Coimbra | 3000 | Portugal |
| Almería | 04009 | Spain |
| Barcelona | 08035 | Spain |
| Burgos | 09005 | Spain |
| Cadiz | 11009 | Spain |
| Esplugues de Llobregat | 08950 | Spain |
| Madrid | 28046 | Spain |
| Mérida-Badajoz | 06800 | Spain |
| Santander | 38003 | Spain |
| Seville | 41013 | Spain |
| Valencia | 46009 | Spain |
| Valladolid | 47010 | Spain |
| Vitoria-Gasteiz | 01004 | Spain |
| Zaragoza | 50009 | Spain |
| Malmö | 205 02 | Sweden |
| Stockholm | 171 76 | Sweden |
| Truro | Cnwll | TR1 3LJ | United Kingdom |
| London | Gt Lon | SE13 6LH | United Kingdom |
| London | Gt Lon | W12 0HS | United Kingdom |
| London | Gt Lon | WC1N 3JH | United Kingdom |
| Manchester | Gt Man | M27 4HA | United Kingdom |
| Edinburgh | Loth | EH16 4SA | United Kingdom |
| Liverpool | Mersyd | L12 2AP | United Kingdom |
| Sheffield | Mersyd | L12 2AP | United Kingdom |
| Oxford | Oxon | OX3 L7J | United Kingdom |
| Sheffield | Syorks | S10 2TH | United Kingdom |
| Cardiff | W Glam | CF4 4XW | United Kingdom |
| Birmingham | Wstmid | B4 6NL | United Kingdom |
| Wolverhampton | Wstmid | WV10 0QP | United Kingdom |
| Leeds | Wyorks | L59 7FF | United Kingdom |
| London | E1 1BB | United Kingdom |
| Plymouth | United Kingdom |
| Poole | BH15 2JB | United Kingdom |
| Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D002836 | Hemophilia B |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D040181 | Genetic Diseases, X-Linked |
Not provided
Not provided