Non-interventional long term study (NIS) for the clinical usage of Biotest IVIGs in various indications (Biotest NIS-020)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41517
• EU PAS number:
  EUPAS41516
• Study ID:
  41517
• Official title and acronym:
  Non-interventional long term study (NIS) for the clinical usage of Biotest IVIGs in various indications (Biotest NIS-020)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The experience gained with immunoglobulin preparations (IVIGs) during the approval phase is limited. Implementation of this post-authorization study serves to check the tolerance profile, effectiveness and patient satisfaction during use in the medical routine in various indications.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biotest

Study timelines

Date when funding contract was signed

Actual: 26/10/2020

Study start date

Actual: 01/06/2021

Data analysis start date

Planned: 02/06/2025

Date of final study report

Planned: 30/12/2025

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