CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02556775
NCT02556775N/ACompleted

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

Baxalta now part of Shire·observational·Posted Sep 22, 2015·Updated Apr 28, 2021

In Brief

An observational study evaluating A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment and HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for Exposure During Pregnancy. Completed, enrolled 16 participants across 8 sites in 5 countries.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCzechia, Germany, Poland, Slovakia, United States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 22, 2015
Enrollment StartDec 4, 2015
Primary CompletionDec 17, 2019
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 10.8 years ago

Interventions

A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatmentbiological

To be determined by the physician

HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]biological

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase