161301 HyQvia Preg Registry

• Research type

  Research Study

• Full title

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

• IRAS ID

  187671

• Contact name

  Stephen Jolles

• Contact email

  Stephen.Jolles@wales.nhs.uk

• Sponsor organisation

  Baxalta

• Duration of Study in the UK

  3 years, 9 months, 31 days

• Research summary

  The purpose of this registry is to acquire safety data, regarding the course and outcome of pregnancy in women ever treated with HyQvia. Development of the fetus/infant at birth and for the first 2 years will also be followed.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  16/NE/0303

• Date of REC Opinion

  2 Sep 2016

• REC opinion

  Favourable Opinion