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Completed

NCT Number: NCT02593188

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

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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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kern Allergy Medical Clinic, Bakersfield, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant requires immunoglobulin treatment for primary immunodeficiency disease (PIDD)
  • Participant age is compatible with local package insert requirements
  • Participant has been prescribed or has started treatment with HYQVIA (Immune Globulin (Human) 10% with rHuPH20)
  • Participant is willing and able to comply with the requirements of the protocol.
  • 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

  • Participant has known hypersensitivity to any of the components of the medicinal product
  • 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
  • Participant is a family member or employee of the investigator
  • Participant is planning to become pregnant, pregnant or breastfeeding at the time of enrollment

Treatment and study plan

HyQvia

Biological

Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2015
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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