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
Oklahoma City, Oklahoma 73120
848
mi
from 43215
Oklahoma City, OK
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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...
484
mi
from 43215
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...
1511
mi
from 43215
Salt Lake City, UT
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
750
mi
from 43215
Tulsa, OK
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582
mi
from 43215
Albany, GA
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2121 17th Street
Bakersfield, California 93301
1980
mi
from 43215
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....
643
mi
from 43215
Boston, MA
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Canton, Michigan 48187
165
mi
from 43215
Canton, MI
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Charlotte, North Carolina 28277
360
mi
from 43215
Charlotte, NC
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Charlotte, North Carolina 28203
349
mi
from 43215
Charlotte, NC
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Colorado Springs, Colorado 80907
1162
mi
from 43215
Colorado Springs, CO
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Colorado Springs, Colorado 80920
1163
mi
from 43215
Colorado Springs, CO
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Columbus, Ohio 43235
9
mi
from 43215
Columbus, OH
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Corning, New York 14830
345
mi
from 43215
Corning, NY
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911
mi
from 43215
Dallas, TX
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Great Neck, New York 11021
491
mi
from 43215
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...
995
mi
from 43215
Houston, TX
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1961
mi
from 43215
Irvine, CA
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McKinney, Texas 75070
890
mi
from 43215
McKinney, TX
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1646
mi
from 43215
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,...
335
mi
from 43215
Milwaukee, WI
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Mineola, New York 11501
496
mi
from 43215
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...
477
mi
from 43215
New York, NY
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Newhall, California 91321
1978
mi
from 43215
Newhall, CA
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517
mi
from 43215
North Charleston, SC
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844
mi
from 43215
Oklahoma City, OK
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Pittsburgh, Pennsylvania 15241
162
mi
from 43215
Pittsburgh, PA
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1711 Vía El Prado
Redondo Beach, California 90277
1986
mi
from 43215
Redondo Beach, CA
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1051
mi
from 43215
Round Rock, TX
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Sacramento, California 95819
2041
mi
from 43215
Sacramento, CA
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Saint Louis, Missouri 63110
398
mi
from 43215
Saint Louis, MO
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7703 Floyd Curl Drive
San Antonio, Texas 78229
1137
mi
from 43215
San Antonio, TX
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Santa Monica, California 90404
1986
mi
from 43215
Santa Monica, CA
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Thornton, Colorado 80233
1158
mi
from 43215
Thornton, CO
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