A Study to Describe Mothers' and Babies' Outcomes After Exposure to HyQvia During Pregnancy

Takeda

Status: Completed

Conditions: Exposure During Pregnancy

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT05803200

TAK-771-4004

EUPAS103800 (Other Identifier)

Details and patient eligibility

About

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.

Full description

This is a non-interventional, retrospective, case series of commercially insured pregnant women exposed to HyQvia during their pregnancy identified according to the MarketScan Research Database. This study will assess maternal characteristics, patterns of HyQvia utilization and pregnancy outcomes in all pregnancies exposed to HyQvia during pregnancy.

This study will enroll approximately at least 7 patients based on feasibility assessment. Participants will be enrolled in the following cohort:

• HyQvia

This study will have a retrospective data collection from 1 January 2014 to 31 December 2020. This study would be conducted in the US.

The overall time for data collection in this study will be approximately 7 years.

Enrollment: 7 patients

Sex: Female

Ages: 16 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria • Exposed to HyQvia in the etiologic window defined as 90 days prior to the LMP until the end of pregnancy.

Exclusion criteria

• NA

Trial design

7 participants in 1 patient group

HyQvia

Description:

Pregnant female participants who have insurance coverage with full prescriptions benefits exposed to HyQvia during the period from 90 days before the last menstrual period (LMP) through 30 days after delivery will be observed retrospectively from 1 January 2014 to 31 December 2020 (up to 7 years).

Treatment:

Drug: No intervention