Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
NCT ID: NCT02593188
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
264 participants
OBSERVATIONAL
2015-11-12
2021-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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HYQVIA- Epoch 1
Participants receiving HYQVIA
HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
HYQVIA- Epoch 2
Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)
HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Interventions
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HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
16 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Shire Director
Role: STUDY_DIRECTOR
Shire
Locations
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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
Allergy / Immunology Research Center of North Texas
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
McKinney Allergy and Asthma Center
McKinney, Texas, United States
Greater Austin Allergy, Asthma, & Immunology
Round Rock, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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EUPAS21523
Identifier Type: REGISTRY
Identifier Source: secondary_id
161406
Identifier Type: -
Identifier Source: org_study_id
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