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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS21523 | Registry Identifier | EU PAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYQVIA- Epoch 1 | Participants receiving HYQVIA |
| |
| HYQVIA- Epoch 2 | Participants with rHuPH antibody titers ≥160 (tested in Epoch 1) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYQVIA | Biological | Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of all related serious adverse events (SAEs) | Throughout the study period of approximately 5 1/2 years | |
| Incidence of all SAEs | Throughout the study period of approximately 5 1/2 years | |
| Incidence of non-serious adverse events (AEs), related and not related, local and systemic. | Throughout the study period of approximately 5 1/2 years | |
| Incidence of Infections | Throughout the study period of approximately 5 1/2 years | |
| Incidence and titer of binding and neutralizing antibodies to rHuPH20 | Throughout the study period of approximately 5 1/2 years | |
| Treatment Regimen: Total dose administered | Throughout the study period of approximately 5 1/2 years | |
| Treatment Regimen: Infusion interval | Throughout the study period of approximately 5 1/2 years | |
| Treatment Administration: Actual volume per infusion | Throughout the study period of approximately 5 1/2 years | |
| Treatment Administration: Maximum infusion rate | Throughout the study period of approximately 5 1/2 years | |
| Treatment Administration: Mean rate of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shire Director | Shire | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kern Allergy Medical Clinic | Bakersfield | California | 93301 | United States | ||
| University of California Irvine Medical Center |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Blood samples (plasma) for antibodies against recombinant human hyaluronidase (rHuPH20) that remain after study testing will be stored at the Central Laboratory to confirm implausible or critical test results, if required. Samples will be stored in a coded form and according to local requirements for a maximum of 2 years after the final study report has been completed and subsequently will be destroyed.
| Throughout the study period of approximately 5 1/2 years |
| Treatment Administration: Duration of infusion | Throughout the study period of approximately 5 1/2 years |
| Treatment Administration: Number of infusion sites per infusion | Throughout the study period of approximately 5 1/2 years |
| Health Related Quality of Life: Short Form-36 (SF-36) | Every 3 months in first year of study, annually for remainder of study |
| Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire | Every 3 months in first year of study, annually for remainder of study |
| Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) | Every 3 months in first year of study, annually for remainder of study |
| Health Related Quality of Life: Treatment Preference Questionnaire | Annually throughout the study |
| Health resource use: hospitalizations | Throughout the study period of approximately 5 1/2 years |
| Health resource use: length of hospital stay | Throughout the study period of approximately 5 1/2 years |
| Health resource use: acute care visits | Throughout the study period of approximately 5 1/2 years |
| Health resource use: Emergency Room visits | Throughout the study period of approximately 5 1/2 years |
| Days missed from work/school | Throughout the study period of approximately 5 1/2 years |
| Irvine |
| California |
| 92697 |
| United States |
| Riviera Allergy Medical Center | Redondo Beach | California | 90277 | United States |
| Capital Allergy & Respiratory Disease Center | Sacramento | California | 95819 | United States |
| UCLA School of Medicine | Santa Monica | California | 90404 | United States |
| Asthma and Allergy Associates, PC | Colorado Springs | Colorado | 80907 | United States |
| Pikes Peak Allergy and Asthma | Colorado Springs | Colorado | 80920 | United States |
| IMMUNOe International Research Centers | Thornton | Colorado | 80233 | United States |
| Georgia Pollens Clinical Research Centers, Inc. | Albany | Georgia | 31707 | United States |
| Boston Childrens Hospital | Boston | Massachusetts | 02115 | United States |
| Canton Health Center | Canton | Michigan | 48187-5097 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Corning Center for Clinical Research | Corning | New York | 14830 | United States |
| Northwell Health, Inc. PRIME | Great Neck | New York | 11021 | United States |
| Winthrop University | Mineola | New York | 11501 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28203 | United States |
| Allergy Asthma & Immunology Relief of Charlotte | Charlotte | North Carolina | 28277 | United States |
| Optimed Research, LTD | Columbus | Ohio | 43235 | United States |
| Allergy, Asthma and Clinical Research Center | Oklahoma City | Oklahoma | 73120 | United States |
| OK Institute of Allergy & Asthma Clinical Research, LLC | Oklahoma City | Oklahoma | 73131 | United States |
| Vital Prospects Clinical Research Institute, P.C. | Tulsa | Oklahoma | 74136 | United States |
| Allergy & Clinical Immunology Associates | Pittsburgh | Pennsylvania | 15241 | United States |
| National Allergy, Asthma & Urticaria Centers of Charleston, PA | North Charleston | South Carolina | 29420-4211 | United States |
| Allergy / Immunology Research Center of North Texas | Dallas | Texas | 75230 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| McKinney Allergy and Asthma Center | McKinney | Texas | 75070 | United States |
| Greater Austin Allergy, Asthma, & Immunology | Round Rock | Texas | 78664-5226 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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