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 |
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.
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
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Utah Research is a major component in the life of the U benefiting...
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
918-392-4550
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
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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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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North Charleston, South Carolina 29406
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7703 Floyd Curl Drive
San Antonio, Texas 78229
San Antonio, Texas 78229
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