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

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ClinicalTrials.gov Identifier: NCT02593188
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Shire ( 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

Study Design
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Study Type : Observational
Estimated Enrollment : 250 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
Estimated Primary Completion Date : June 12, 2021
Estimated Study Completion Date : June 12, 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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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


Contacts
Contact: Salvador Dominguez +1-617-588-8347 Salvador.Dominguez@shire.com

  Show 34 Study Locations
Sponsors and Collaborators
Baxalta now part of Shire
Investigators
Study Director: Leman Yel, MD Shire
More Information
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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT02593188     History of Changes
Other Study ID Numbers: 161406
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases