Haemonine - Post marketing study for long-term treatment of Haemophilia B patients (NIS Haemonine)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33097
• EU PAS number:
  EUPAS8060
• Study ID:
  33097
• Official title and acronym:
  Haemonine - Post marketing study for long-term treatment of Haemophilia B patients (NIS Haemonine)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The post marketing study (PMS) aims to enhance knowledge on the safety profile and effectiveness of Haemonine in the long-term treatment of Haemophilia B patients. Based on the developmental data, there is no particular safety concern for Haemonine. It is expected that the existing safety profile is confirmed by the collection of real life data derived from this study.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Multiple centres: 10 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 05/11/2009

Study start date

Actual: 07/12/2009

Data analysis start date

Planned: 30/06/2019

Actual: 30/06/2019

Date of interim report, if expected

Actual: 23/07/2014

Date of final study report

Planned: 31/12/2019

Actual: 12/08/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biotest AG

Regulatory

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