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

Completed

Conditions studied: Primary Immunodeficiency Diseases (PID)

In brief

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.

Key facts

Study ID

NCT02593188

Run by

Baxalta now part of Shire

People needed

264

Starts

2015-11-12

Expected to finish

2021-10-21

Last updated by the study team

2022-10-18

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
• Participant age is compatible with local package insert requirements
• Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
• Participant is willing and able to comply with the requirements of the protocol.
• 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 may not qualify if…

• Participant has known hypersensitivity to any of the components of the medicinal product
• 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
• Participant is a family member or employee of the investigator
• Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Where it is running

• Kern Allergy Medical Clinic — Bakersfield, California, United States
• University of California Irvine Medical Center — Irvine, California, United States
• Riviera Allergy Medical Center — Redondo Beach, California, United States
• Capital Allergy & Respiratory Disease Center — Sacramento, California, United States
• UCLA School of Medicine — Santa Monica, California, United States
• Asthma and Allergy Associates, PC — Colorado Springs, Colorado, United States
• Pikes Peak Allergy and Asthma — Colorado Springs, Colorado, United States
• IMMUNOe International Research Centers — Thornton, Colorado, United States
• Georgia Pollens Clinical Research Centers, Inc. — Albany, Georgia, United States
• Boston Childrens Hospital — Boston, Massachusetts, United States
• Canton Health Center — Canton, Michigan, United States
• Washington University — St Louis, Missouri, United States
• Corning Center for Clinical Research — Corning, New York, United States
• Northwell Health, Inc. PRIME — Great Neck, New York, United States
• Winthrop University — Mineola, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Carolinas Healthcare System — Charlotte, North Carolina, United States
• Allergy Asthma & Immunology Relief of Charlotte — Charlotte, North Carolina, United States
• Optimed Research, LTD — Columbus, Ohio, United States
• Allergy, Asthma and Clinical Research Center — Oklahoma City, Oklahoma, United States
• OK Institute of Allergy & Asthma Clinical Research, LLC — Oklahoma City, Oklahoma, United States
• Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
• Allergy & Clinical Immunology Associates — Pittsburgh, Pennsylvania, United States
• National Allergy, Asthma & Urticaria Centers of Charleston, PA — North Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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