BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI®

Study identification

• EU PAS number:
  EUPAS1000000614
• Study ID:
  1000000614
• Official title and acronym:
  BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated with BRIUMVI®
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The BRIUMVI™ Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between BRIUMVI™ exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. ; ; The outcomes of interest include major congenital malformations (MCMs; primary outcome), minor congenital malformations, gestational hypertension, pre-eclampsia, eclampsia, gestational diabetes, spontaneous abortions (SAB), stillbirths, elective terminations, small for gestational age (SGA), preterm births, postnatal growth deficiency, infant developmental delays, infant serious or opportunistic infections, and infant hospitalizations.
• Study status:
  Ongoing

Research institutions and networks

Institutions

TG Therapeutics, Inc.

Study timelines

Date when funding contract was signed

Planned:08/09/2023

Actual:08/09/2023

Study start date

Planned:31/05/2024

Actual:31/05/2024

Date of final study report

Planned:31/03/2035

Sources of funding

Pharmaceutical company and other private sector 

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)