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

NCT02556775 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-04-28

Study results available
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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.

Conditions

  • Exposure During Pregnancy

Interventions

BIOLOGICAL

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

To be determined by the physician

BIOLOGICAL

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

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

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Shire Director · Shire

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-04
Primary Completion
2019-12-17
Completion
2019-12-17

Countries

  • United States
  • Czechia
  • Germany
  • Poland
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02556775 on ClinicalTrials.gov