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.

Study Overview

• Status: Completed
• Conditions: Primary Immunodeficiency Diseases (PID)
• Intervention / Treatment: Biological: HYQVIA

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93301
      • Kern Allergy Medical Clinic
    • Irvine, California, United States, 92697
      • University of California Irvine Medical Center
    • Redondo Beach, California, United States, 90277
      • Riviera Allergy Medical Center
    • Sacramento, California, United States, 95819
      • Capital Allergy & Respiratory Disease Center
    • Santa Monica, California, United States, 90404
      • UCLA School of Medicine
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Asthma and Allergy Associates, PC
    • Colorado Springs, Colorado, United States, 80920
      • Pikes Peak Allergy and Asthma
    • Thornton, Colorado, United States, 80233
      • IMMUNOe International Research Centers
  • Georgia
    • Albany, Georgia, United States, 31707
      • Georgia Pollens Clinical Research Centers, Inc.
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Childrens Hospital
  • Michigan
    • Canton, Michigan, United States, 48187-5097
      • Canton Health Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Corning, New York, United States, 14830
      • Corning Center for Clinical Research
    • Great Neck, New York, United States, 11021
      • Northwell Health, Inc. PRIME
    • Mineola, New York, United States, 11501
      • Winthrop University
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Healthcare System
    • Charlotte, North Carolina, United States, 28277
      • Allergy Asthma & Immunology Relief of Charlotte
  • Ohio
    • Columbus, Ohio, United States, 43235
      • Optimed Research, LTD
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma and Clinical Research Center
    • Oklahoma City, Oklahoma, United States, 73131
      • OK Institute of Allergy & Asthma Clinical Research, LLC
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy & Clinical Immunology Associates
  • South Carolina
    • North Charleston, South Carolina, United States, 29420-4211
      • National Allergy, Asthma & Urticaria Centers of Charleston, PA
  • Texas
    • Dallas, Texas, United States, 75230
      • Allergy / Immunology Research Center of North Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • McKinney, Texas, United States, 75070
      • McKinney Allergy and Asthma Center
    • Round Rock, Texas, United States, 78664-5226
      • Greater Austin Allergy, Asthma, & Immunology
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baxalta now part of Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2015
• Primary Completion (Actual): October 21, 2021
• Study Completion (Actual): October 21, 2021

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): November 1, 2015

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: 161406; EUPAS21523 (Registry Identifier: EU PAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR