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
Colorado Springs, Colorado 80907
803
mi
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Colorado Springs, CO
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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...
2438
mi
from 91732
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...
572
mi
from 91732
Salt Lake City, UT
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
1254
mi
from 91732
Tulsa, OK
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1964
mi
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Albany, GA
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2121 17th Street
Bakersfield, California 93301
106
mi
from 91732
Bakersfield, CA
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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....
2578
mi
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Boston, MA
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Canton, Michigan 48187
1943
mi
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Canton, MI
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Charlotte, North Carolina 28277
2104
mi
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Charlotte, NC
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Charlotte, North Carolina 28203
2101
mi
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Charlotte, NC
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Colorado Springs, Colorado 80920
802
mi
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Colorado Springs, CO
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Columbus, Ohio 43235
1957
mi
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Columbus, OH
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Corning, New York 14830
2272
mi
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Corning, NY
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1224
mi
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Dallas, TX
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Great Neck, New York 11021
2446
mi
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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...
1357
mi
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Houston, TX
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31
mi
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Irvine, CA
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McKinney, Texas 75070
1225
mi
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McKinney, TX
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364
mi
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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,...
1722
mi
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Milwaukee, WI
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Mineola, New York 11501
2451
mi
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Mineola, NY
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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...
2432
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New York, NY
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Newhall, California 91321
36
mi
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Newhall, CA
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2179
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North Charleston, SC
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1167
mi
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73120
1162
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Oklahoma City, OK
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Pittsburgh, Pennsylvania 15241
2119
mi
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Pittsburgh, PA
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1711 Vía El Prado
Redondo Beach, California 90277
27
mi
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Redondo Beach, CA
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1210
mi
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Round Rock, TX
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Sacramento, California 95819
364
mi
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Sacramento, CA
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Saint Louis, Missouri 63110
1568
mi
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Saint Louis, MO
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7703 Floyd Curl Drive
San Antonio, Texas 78229
1182
mi
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San Antonio, TX
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Santa Monica, California 90404
27
mi
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Santa Monica, CA
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Thornton, Colorado 80233
824
mi
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Thornton, CO
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