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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02593188
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Primary Immunodeficiency Diseases (PID) Biological: HYQVIA

Detailed Description:
Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Study Design
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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Actual Study Start Date : November 12, 2015
Actual Primary Completion Date : October 21, 2021
Actual Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
HYQVIA- Epoch 1
Participants receiving HYQVIA
 Biological: HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
HYQVIA- Epoch 2
Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)
 Biological: HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of all related serious adverse events (SAEs) [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  2. Incidence of all SAEs [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  3. Incidence of non-serious adverse events (AEs), related and not related, local and systemic. [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  4. Incidence of Infections [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  5. Incidence and titer of binding and neutralizing antibodies to rHuPH20 [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  6. Treatment Regimen: Total dose administered [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  7. Treatment Regimen: Infusion interval [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  8. Treatment Administration: Actual volume per infusion [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  9. Treatment Administration: Maximum infusion rate [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  10. Treatment Administration: Mean rate of infusion [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  11. Treatment Administration: Duration of infusion [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  12. Treatment Administration: Number of infusion sites per infusion [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  13. Health Related Quality of Life: Short Form-36 (SF-36) [ Time Frame: Every 3 months in first year of study, annually for remainder of study ]
  14. Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire [ Time Frame: Every 3 months in first year of study, annually for remainder of study ]
  15. Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) [ Time Frame: Every 3 months in first year of study, annually for remainder of study ]
  16. Health Related Quality of Life: Treatment Preference Questionnaire [ Time Frame: Annually throughout the study ]
  17. Health resource use: hospitalizations [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  18. Health resource use: length of hospital stay [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  19. Health resource use: acute care visits [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  20. Health resource use: Emergency Room visits [ Time Frame: Throughout the study period of approximately 5 1/2 years ]
  21. Days missed from work/school [ Time Frame: Throughout the study period of approximately 5 1/2 years ]

Biospecimen Retention:   Samples Without DNA
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.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593188


Locations
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Sponsors and Collaborators
Baxalta now part of Shire
Investigators
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Study Director: Shire Director Shire
More Information
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02593188    
Other Study ID Numbers: 161406
EUPAS21523 ( Registry Identifier: EU PAS )
First Posted: November 1, 2015    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Access Criteria: 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.
URL: https://vivli.org/ourmember/takeda/
Additional relevant MeSH terms:
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Primary Immunodeficiency Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn