The Benralizumab Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45903
• EU PAS number:
  EUPAS26461
• Study ID:
  45903
• Official title and acronym:
  The Benralizumab Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance Study
• DARWIN EU® study:
  No
• Study countries:
  Canada

  United States
• Study status:
  Finalised

Research institution and networks

Institutions

Organization of Teratology Information Specialists (OTIS)

University California SD

Networks

Organization of Teratology Information Specialists (OTIS) Network

Study timelines

Date when funding contract was signed

Planned: 20/12/2017

Actual: 20/12/2017

Study start date

Planned: 01/09/2018

Actual: 20/03/2019

Data analysis start date

Planned: 01/11/2025

Actual: 26/12/2023

Date of interim report, if expected

Planned: 15/12/2019

Actual: 12/12/2018

Date of final study report

Planned: 30/03/2027

Actual: 23/08/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca AB

Study protocol

Initial protocol

d3250r00026-csp-v2_Redacted_15Nov2018

Updated protocol

d3250r00026-csp-v3_Redacted_27Jul2020(final version)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D3250R00026