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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00167973
• Collaborator: (none)
• Enrollment: 218
• Locations: 91
• Duration (Months): 89
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemophilia B

Study Design

• Study Type: Observational
• Actual Enrollment: 218 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
• Study Start Date: Jan 1, 2002
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Outcome Measures

Primary Outcome Measures

1. Observation for safety [Study Duration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Vienna		Austria	1090
2		Brussels		Belgium	1200
3		Brussel		Belgium	1090
4		Bruxelles		Belgium	1020
5		Edegem		Belgium	2650
6		Leuven		Belgium	3000
7		Montegnée		Belgium	4420
8		Amiens Cedex		France	80 80054
9		Angers Cedex 01		France	49 49033
10		Caen Cedex		France	14 14033
11		Chambery Cedex		France	73 73011
12		Grenoble Cedex 09		France	38 38043
13		Le Chesnay Cedex		France	78 78153
14		Le Kremlin Bicetre Cedex		France	94 94279
15		Liffre		France	35 35340
16		Limoges		France	87 87042
17		Lyon Cedex		France	03 69437
18		Lyon		France	69 69000
19		Marseille Cedex 5		France	13 13385
20		Montmorency		France	95 95160
21		Montpellier Cedex 5		France	34 34295
22		Montpellier Cedex		France	34 34059
23		Nantes Cedex		France	44 44093
24		Nevers		France	58 58020
25		Nice Cedex		France	06 06202
26		Osseja Cedex		France	66 66344
27		Paris Cedex 14		France	75 75674
28		Paris Cedex 15		France	75 75743
29		Rouen		France	76 76031
30		Saint Priest en Jarez		France	42 42270
31		St Priest en Jarez		France	42 42270
32		Tours Cedex		France	37 37044
33		Erlangen	BY	Germany	91054
34		Hamburg	HH	Germany	20246
35		Muenster	NW	Germany	48143
36		Ancona	AN	Italy	60100
37		Bari	BA	Italy	70124
38		Catania	CT	Italy	95124
39		Catanzaro	CZ	Italy	88100
40		Milano	MI	Italy	20162
41		Palermo	PA	Italy	90134
42		Pescara	PE	Italy	65100
43		Parma	PR	Italy	43100
44		Reggio Calabria	RC	Italy	89100
45		Sassari	SS	Italy	07100
46		Napoli		Italy	80131
47		Padova		Italy
48		Palermo		Italy	90100
49		Perugia		Italy	06126
50		Roma		Italy	00161
51		Vicenza		Italy	36100
52		Amsterdam		Netherlands	1007 MB
53		Breda		Netherlands	4818 CK
54		Eindhoven		Netherlands	5623 EJ
55		Maastricht		Netherlands	6229 HX
56		Nijmegen		Netherlands	6525 GA
57		Utrecht		Netherlands	3584 CX
58		Coimbra		Portugal	3000
59		Almeria		Spain	04009
60		Barcelona		Spain	08035
61		Burgos		Spain	09005
62		Cadiz		Spain	11009
63		Esplugues de Llobregat		Spain	08950
64		Madrid		Spain	28046
65		Mérida-Badajoz		Spain	06800
66		Santander		Spain	38003
67		Sevilla		Spain	41013
68		Valencia		Spain	46009
69		Valladolid		Spain	47010
70		Vitoria		Spain	01004
71		Zaragoza		Spain	50009
72		Malmö		Sweden	205 02
73		Stockholm		Sweden	171 76
74		Truro	Cnwll	United Kingdom	TR1 3LJ
75		London	Gt Lon	United Kingdom	SE13 6LH
76		London	Gt Lon	United Kingdom	W12 0HS
77		London	Gt Lon	United Kingdom	WC1N 3JH
78		Manchester	Gt Man	United Kingdom	M27 4HA
79		Edinburgh	Loth	United Kingdom	EH16 4SA
80		Liverpool	Mersyd	United Kingdom	L12 2AP
81		Sheffield	Mersyd	United Kingdom	L12 2AP
82		Oxford	Oxon	United Kingdom	OX3 L7J
83		Sheffield	Syorks	United Kingdom	S10 2TH
84		Cardiff	W Glam	United Kingdom	CF4 4XW
85		Birmingham	Wstmid	United Kingdom	B4 6NL
86		Wolverhampton	Wstmid	United Kingdom	WV10 0QP
87		Leeds	Wyorks	United Kingdom	L59 7FF
88		London		United Kingdom	E1 1BB
89		Plymouth		United Kingdom
90		Poole		United Kingdom	BH15 2JB
91		Sheffield		United Kingdom	S10 2JF

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer
• Principal Investigator: Trial mANAGER, For Germany, [e-mail]
• Principal Investigator: Trial Manager, For Italy, [e-mail]
• Principal Investigator: Trial Manager, For Belgium, [e-mail]
• Principal Investigator: Trial Manager, For Netherlands, [e-mail]
• Principal Investigator: Trial Manager, For Sweden, [e-mail]
• Principal Investigator: Trial Manager, For Austria, [e-mail]
• Principal Investigator: Trial Manager, For UK, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00167973
• Other Study ID Numbers: 3090A-101039
• First Posted: Sep 14, 2005
• Last Update Posted: May 26, 2010
• Last Verified: May 1, 2010

• Keywords provided by , ,: Hemophilia B
• Additional relevant MeSH terms: Hemophilia A; Hemophilia B

Study Results

No Results Posted as of May 26, 2010