C1 inhibitor Treatment Registry to assess the Safety and Immunological Profile of Ruconest in the treatment of HAE Attacks (Ruconest Registry)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38421
• EU PAS number:
  EUPAS7375
• Study ID:
  38421
• Official title and acronym:
  C1 inhibitor Treatment Registry to assess the Safety and Immunological Profile of Ruconest in the treatment of HAE Attacks (Ruconest Registry)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Croatia

  France

  Germany

  Hungary

  Italy

  Norway

  Poland

  Slovakia

  Slovenia

  Sweden
• Study description:
  Non-interventional treatment Registry of HAE patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)
• Study status:
  Finalised

Research institutions and networks

Institutions

Pharming Technologies

Study timelines

Date when funding contract was signed

Planned: 06/10/2011

Actual: 06/10/2011

Study start date

Planned: 06/10/2011

Actual: 06/10/2011

Data analysis start date

Actual: 11/12/2024

Date of final study report

Planned: 31/12/2021

Actual: 24/03/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pharming Technologies BV

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)