091301: FEIBA NF GLOBAL OUTCOME STUDY (FEIBA-GO) (091301: FEIBA-GO)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/43046
• EU PAS number:
  EUPAS6691
• Study ID:
  43046
• Official title and acronym:
  091301: FEIBA NF GLOBAL OUTCOME STUDY (FEIBA-GO) (091301: FEIBA-GO)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Hungary

  Italy

  Norway

  Poland

  Portugal

  Russian Federation

  Spain

  United Kingdom
• Study description:
  The 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 30/09/2013

Actual: 30/09/2013

Study start date

Planned: 30/06/2014

Actual: 03/09/2014

Data analysis start date

Planned: 28/02/2020

Actual: 28/02/2020

Date of final study report

Planned: 30/10/2020

Actual: 26/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Shire

Study protocol

Initial protocol

091301-protocol-original-redact

Updated protocol

091301-protocol-amendment 2-redact

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable