TAK-771-4004: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106550
• EU PAS number:
  EUPAS103800
• Study ID:
  106550
• Official title and acronym:
  TAK-771-4004: Maternal and Infant Characteristics and Outcomes Following Exposure to HyQvia During Pregnancy: A Case Series Study Based on US Claims Data
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The main aim of this study is to provide further information on the safety profile of HyQvia during pregnancy. This will be done by checking the characteristics of the mother and their babies. They will also be checked for any safety outcomes that will occur when exposed to HyQvia during pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Takeda

Study timelines

Date when funding contract was signed

Planned: 24/02/2023

Actual: 24/02/2023

Study start date

Planned: 15/03/2023

Actual: 15/03/2023

Data analysis start date

Planned: 16/04/2023

Actual: 16/04/2023

Date of final study report

Planned: 30/06/2023

Actual: 16/06/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Study protocol

Initial protocol

TAK-771-4004-clinical-study-protocol-redact

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable