Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

Study identification

• EU PAS number:
  EUPAS21523
• Study ID:
  49332
• Official title and acronym:
  Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and product administration in routine clinical practice.
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 02/03/2015

Actual: 17/09/2015

Study start date

Planned: 12/11/2015

Actual: 12/11/2015

Data analysis start date

Planned: 30/10/2021

Actual: 21/10/2021

Date of final study report

Planned: 16/05/2022

Actual: 16/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta, now part of Shire

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)