NN7008-3553 A Multi-centre Non-interventional Study of Safety and Efficacy of turoctocog alfa (rFVIII) during Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII ≤2%) (guardian™ 5)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/39037
• EU PAS number:
  EUPAS5501
• Study ID:
  39037
• Official title and acronym:
  NN7008-3553 A Multi-centre Non-interventional Study of Safety and Efficacy of turoctocog alfa (rFVIII) during Long-Term Treatment of Severe and Moderately Severe Haemophilia A (FVIII ≤2%) (guardian™ 5)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Greece

  Hungary

  Italy

  Netherlands

  Poland

  Slovakia

  Slovenia

  Switzerland

  United States
• Study description:
  This study is conducted in Europe, and North and South America. The aim of this study is to provide additional documentation of the immunogenicity, and obtain additional clinical data, of turoctocog alfa in the setting of normal clinical practise in patients previously treated with a factor VIII agent (FVIII).
• Study status:
  Finalised

Research institution and networks

Institutions

Novo Nordisk

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 26/01/2014

Actual: 26/01/2014

Study start date

Actual: 05/06/2014

Date of interim report, if expected

Planned: 01/11/2016

Date of final study report

Planned: 15/01/2021

Actual: 08/01/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

3553-protocol-version-3_Redacted

Updated protocol

3553-protocol-version-8-redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)