Non-interventional prospective safety study as part of the routine pharmacovigilance in patients treated with Intratect 100 g / l (German title: Nicht-interventionelle prospektive Unbedenklichkeitsstudie im Rahmen der Routine-Pharmakovigilanz bei Intratect 100 g/l behandelten Patienten) (NIS Intratect 100 g/l)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27175
• EU PAS number:
  EUPAS8040
• Study ID:
  27175
• Official title and acronym:
  Non-interventional prospective safety study as part of the routine pharmacovigilance in patients treated with Intratect 100 g / l (German title: Nicht-interventionelle prospektive Unbedenklichkeitsstudie im Rahmen der Routine-Pharmakovigilanz bei Intratect 100 g/l behandelten Patienten) (NIS Intratect 100 g/l)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The primary objective of the study is to gain additional insights on tolerance by broadening the database under real life conditions. Secondary objectives are to broaden the of knowledge on the effectiveness and to identify patients at risk due to pre-existing illnesses and risk factors
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Multiple centres: 47 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 28/01/2013

Study start date

Actual: 01/03/2013

Data analysis start date

Actual: 01/10/2021

Date of interim report, if expected

Planned: 30/06/2019

Date of final study report

Planned: 30/06/2022

Actual: 22/08/2022

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

Other study registration identification numbers and links

Biotest NIS-011