Pregnancy Registry to collect Long-Term Safety Data from Women treated with HyQvia

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/46485
• EU PAS number:
  EUPAS5798
• Study ID:
  46485
• Official title and acronym:
  Pregnancy Registry to collect Long-Term Safety Data from Women treated with HyQvia
• DARWIN EU® study:
  No
• Study countries:
  Czechia

  Germany

  Poland

  Slovakia

  United States
• Study description:
  This study is a non-interventional, prospective, uncontrolled, two-arm, open-label, multicenter post-authorization pregnancy registry of women ever treated with HyQvia. Subjects who prior to the study received HyQvia and at enrollment receive a licensed human normal immunoglobulin other than HyQvia or an alternative treatment during the study will be assigned to Study Arm 1 (Alternative Product Arm), subjects in countries, where HyQvia treatment during pregnancy is not indicated, should be enrolled in this arm. Subjects who continue treatment with HyQvia during pregnancy will be followed in Study Arm 2 (HyQvia Arm). The registry is designed according to the CHMP Guideline on the exposure to medicinal products during pregnancy: Need for post authorisation data, and the U.S. Department of Health and Human Services Guidance for Industry: Establishing Pregnancy Exposure Registries. Female patients being treated with HyQvia will notify their treating physician (for example their immunologist) immediately of the pregnancy. Baxalta now part of Shire plans to have 1 coordinating center per country, with as many satellite sites as needed (sites where the pregnant women will be seen/treated).
• Study status:
  Finalised

Research institutions and networks

Institutions

Shire

Multiple centres: 5 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 27/06/2013

Actual: 27/06/2013

Study start date

Planned: 29/08/2014

Actual: 04/12/2015

Date of final study report

Planned: 28/02/2021

Actual: 10/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Baxalta Innovations GmbH, now part of Shire

Study protocol

Initial protocol

161301_protocol amendment 3_22Oct2015_redacted

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)