Status: Finalised First registered on: 24/06/2014
Last updated on: 15/09/2021
1. Study identification
EU PAS Register NumberEUPAS6691
Official title091301: FEIBA NF GLOBAL OUTCOME STUDY (FEIBA-GO)
Study title acronym091301: FEIBA-GO
Study typeObservational study
Brief description of the studyThe study addresses the need to measure long-term effectiveness, safety and quality of life outcome measures for haemophilia A or B patients with high-responding inhibitors treated on-demand and in prophylaxis with FEIBA NF. The purpose of the study is to document the natural history of hemophilia A or B disease in subjects with high responding inhibitors either to Factor VIII or Factor IX and to describe long-term outcomes in terms of effectiveness, safety and quality of life in subjects receiving FEIBA NF in routine clinical practice.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameBaxalta Innovations GmbH, now part of Shire
Centre locationVienna, Austria
Details of (Primary) lead investigator
Title Mr
Last name Shire
First name Study Contact
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?40
Countries in which this study is being conducted
International study

France
Germany
Hungary
Italy
Norway
Poland
Portugal
Russian Federation
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/09/201330/09/2013
Start date of data collection30/06/201403/09/2014
Start date of data analysis28/02/202028/02/2020
Date of interim report, if expected
Date of final study report30/10/202026/11/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBaxalta Innovations GmbH, now part of Shire100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Mr
Last name Shire
First name Study Contact
Address line 1300 Shire Way
Address line 2 
Address line 3 
CityLexington 
Postcode 
CountryUnited States
Phone number (incl. country code)1-866-8425335 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltransparency@shire.com
Public Enquiries
Title Mr 
Last name Shire 
First name Study Contact 
Address line 1300 Shire Way 
Address line 2 
Address line 3 
CityLexington 
Postcode02421 
CountryUnited States 
Phone number (incl. country code)1-866-8425335 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltransparency@shire.com 
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