Immunoglobulin substitution for infection prevention and treatment of primary and secondary immune deficiency syndromes (German title: Immunoglobulinsubstitution zur Infektionsprävention und Behandlung bei primären und sekundären Immunmangelsyndromen) (NIS Intratect 50g/l)

Study identification

• EU PAS number:
  EUPAS7969
• Study ID:
  27431
• Official title and acronym:
  Immunoglobulin substitution for infection prevention and treatment of primary and secondary immune deficiency syndromes (German title: Immunoglobulinsubstitution zur Infektionsprävention und Behandlung bei primären und sekundären Immunmangelsyndromen) (NIS Intratect 50g/l)
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  Rationale and background: The experience with immunoglobulins (IVIGs) obtained in clinical trials for registration is limited. The current non-interventional study is conducted to confirm the safety and effectiveness of the IVIG Intratect (50 g/l) with real life data from daily practice. Study design: Non-interventional, national, multicenter, prospective, observational study
• Study status:
  Finalised

Research institutions and networks

Institutions

Biotest

Multiple centres: 115 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 01/04/2011

Study start date

Actual: 01/04/2011

Data analysis start date

Planned: 02/01/2022

Actual: 01/10/2021

Date of final study report

Planned: 30/06/2022

Actual: 27/09/2022

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