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

October 14, 2022 updated by: Baxalta now part of Shire
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of all related serious adverse events (SAEs)
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Incidence of all SAEs
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
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
Throughout the study period of approximately 5 1/2 years
Incidence of Infections
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Incidence and titer of binding and neutralizing antibodies to rHuPH20
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Total dose administered
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Infusion interval
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Administration: Actual volume per infusion
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Administration: Maximum infusion rate
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Administration: Mean rate of infusion
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Administration: Duration of infusion
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Treatment Administration: Number of infusion sites per infusion
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
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
Every 3 months in first year of study, annually for remainder of study
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
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)
Time Frame: Every 3 months in first year of study, annually for remainder of study
Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Preference Questionnaire
Time Frame: Annually throughout the study
Annually throughout the study
Health resource use: hospitalizations
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Health resource use: length of hospital stay
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Health resource use: acute care visits
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Health resource use: Emergency Room visits
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years
Days missed from work/school
Time Frame: Throughout the study period of approximately 5 1/2 years
Throughout the study period of approximately 5 1/2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxalta now part of Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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