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



Status:Recruiting
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:16 - Any
Updated:2/8/2019
Start Date:November 12, 2015
End Date:June 12, 2021
Contact:Shire Contact
Email:clinicaltransparency@shire.com
Phone:+1 866 842 5335

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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.


Inclusion Criteria:

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

Exclusion Criteria:

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
We found this trial at
34
sites
6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albany, GA
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2121 17th Street
Bakersfield, California 93301
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Canton, Michigan 48187
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Charlotte, North Carolina 28277
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Charlotte, North Carolina 28203
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Colorado Springs, Colorado 80907
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Colorado Springs, Colorado 80920
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Columbus, Ohio 43235
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Corning, New York 14830
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Dallas, TX
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Great Neck, New York 11021
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Great Neck, NY
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Irvine, CA
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McKinney, Texas 75070
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Mesa, AZ
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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Mineola, New York 11501
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newhall, California 91321
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North Charleston, SC
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73120
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Pittsburgh, Pennsylvania 15241
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1711 Vía El Prado
Redondo Beach, California 90277
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Round Rock, TX
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Sacramento, California 95819
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Saint Louis, Missouri 63110
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7703 Floyd Curl Drive
San Antonio, Texas 78229
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Santa Monica, California 90404
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Thornton, Colorado 80233
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