Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)

a study on Primary Immunodeficiency Diseases

Summary

for people ages 16 years and up (full criteria)
at Irvine, California and other locations
study started
estimated completion

Description

Summary

The purpose of the proposed study is to acquire additional data (including the assessment of anti-rHuPH20 antibodies) on the long-term safety of HYQVIA and to assess the prescribed treatment regimens and treatment administration in routine clinical practice.

Keywords

Primary Immunodeficiency Diseases (PID)Immunologic Deficiency SyndromesHYQVIAHYQVIA- Epoch 1HYQVIA- Epoch 2

Eligibility

You can join if…

Open to people ages 16 years and up

  1. Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
  2. Participant age is compatible with local package insert requirements
  3. Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
  4. Participant is willing and able to comply with the requirements of the protocol.
  5. Female participant of child-bearing potential agrees to inform the investigator if she becomes pregnant, or plans to become pregnant during the course of the study

You CAN'T join if...

  1. Participant has known hypersensitivity to any of the components of the medicinal product
  2. Participant has participated in an interventional clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in an interventional clinical study involving a medical product or device during the course of this study
  3. Participant is a family member or employee of the investigator
  4. Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Locations

  • University of California Irvine Medical Centeraccepting new patients
    IrvineCalifornia92697United States
  • Riviera Allergy Medical Centeraccepting new patients
    Redondo BeachCalifornia90277United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Baxalta now part of Shire
ID
NCT02593188
Study Type
Observational
Last Updated