Pregnancy Registry to Collect Long-Term Safety Data From Women Treated With HyQvia

Completed

Conditions studied: Exposure During Pregnancy

In brief

The purpose of this registry is to acquire safety data (including assessment of anti-rHuPH20 antibodies), 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.

Key facts

Study ID

NCT02556775

Run by

Baxalta now part of Shire

People needed

16

Starts

2015-12-04

Expected to finish

2019-12-17

Last updated by the study team

2021-04-28

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• For the expectant mother only: Participant became pregnant during or after treatment with HYQVIA
• Participant/Participant's legally authorized representative is willing to sign an informed consent form (ICF)

You may not qualify if…

• There are no applicable Exclusion Criteria

Where it is running

• QuintilesIMS Plaza Building — Durham, North Carolina, United States
• Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
• Freiburg University Hospital/ Prof. Dr. med. Bodo Grimbacher — Freiburg im Breisgau, Baden-Wurttemberg, Germany
• Universitaetsklinikum Wuerzburg — Würzburg, Bavaria, Germany
• Klinikum St. Georg GmbH — Leipzig, Saxony, Germany
• Wojskowy Instytut Medyczny — Warsaw, Poland
• Onkologicky ustav svatej Alzbety s.r.o. — Bratislava, Slovakia
• RAFMED s.r.o — Košice, Slovakia

Full record on ClinicalTrials.gov

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