Primary Immunodeficiency Diseases (PID)NCT02593188
Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
An observational study of Primary Immunodeficiency Diseases (PID), run by Baxalta now part of Shire at 30 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PID)
- What is being tested?
- HYQVIA
- Type of treatment
- Injection or infusion
- How many people
- 264 participants
- Where
- 30 sitesUnited States
- Study dates
- 12 Nov 2015to 21 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Georgia Pollens Clinical Research Centers, Inc.
Albany, Georgia, 31707
Kern Allergy Medical Clinic
Bakersfield, California, 93301
Boston Childrens Hospital
Boston, Massachusetts, 02115
Canton Health Center
Canton, Michigan, 48187-5097
Carolinas Healthcare System
Charlotte, North Carolina, 28203
Allergy Asthma & Immunology Relief of Charlotte
Charlotte, North Carolina, 28277
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Pikes Peak Allergy and Asthma
Colorado Springs, Colorado, 80920
Optimed Research, LTD
Columbus, Ohio, 43235
Corning Center for Clinical Research
Corning, New York, 14830
Allergy / Immunology Research Center of North Texas
Dallas, Texas, 75230
Northwell Health, Inc. PRIME
Great Neck, New York, 11021
Texas Children's Hospital
Houston, Texas, 77030
University of California Irvine Medical Center
Irvine, California, 92697
McKinney Allergy and Asthma Center
McKinney, Texas, 75070
Winthrop University
Mineola, New York, 11501
Columbia University Medical Center
New York, New York, 10032
National Allergy, Asthma & Urticaria Centers of Charleston, PA
North Charleston, South Carolina, 29420-4211
Allergy, Asthma and Clinical Research Center
Oklahoma City, Oklahoma, 73120
OK Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Riviera Allergy Medical Center
Redondo Beach, California, 90277
Greater Austin Allergy, Asthma, & Immunology
Round Rock, Texas, 78664-5226
Capital Allergy & Respiratory Disease Center
Sacramento, California, 95819
University of Utah
Salt Lake City, Utah, 84132
UCLA School of Medicine
Santa Monica, California, 90404
Washington University
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
IMMUNOe International Research Centers
Thornton, Colorado, 80233
Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, 74136
About this study
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.
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Being tested
- HYQVIA
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYQVIABiological
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
| Study group | Role | What they receive |
|---|---|---|
| HYQVIA- Epoch 1 | Participants receiving HYQVIA Receives: Biological: HYQVIA | |
| HYQVIA- Epoch 2 | Participants with rHuPH antibody titers ≥160 (tested in Epoch 1) Receives: Biological: HYQVIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of all related serious adverse events (SAEs)
Measured: Throughout the study period of approximately 5 1/2 years
Incidence of all SAEs
Measured: Throughout the study period of approximately 5 1/2 years
Incidence of non-serious adverse events (AEs), related and not related, local and systemic.
Measured: Throughout the study period of approximately 5 1/2 years
Incidence of Infections
Measured: Throughout the study period of approximately 5 1/2 years
Incidence and titer of binding and neutralizing antibodies to rHuPH20
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Total dose administered
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Regimen: Infusion interval
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Actual volume per infusion
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Maximum infusion rate
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Mean rate of infusion
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Duration of infusion
Measured: Throughout the study period of approximately 5 1/2 years
Treatment Administration: Number of infusion sites per infusion
Measured: Throughout the study period of approximately 5 1/2 years
Health Related Quality of Life: Short Form-36 (SF-36)
Measured: Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire
Measured: 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)
Measured: Every 3 months in first year of study, annually for remainder of study
Health Related Quality of Life: Treatment Preference Questionnaire
Measured: Annually throughout the study
Health resource use: hospitalizations
Measured: Throughout the study period of approximately 5 1/2 years
Health resource use: length of hospital stay
Measured: Throughout the study period of approximately 5 1/2 years
Health resource use: acute care visits
Measured: Throughout the study period of approximately 5 1/2 years
Health resource use: Emergency Room visits
Measured: Throughout the study period of approximately 5 1/2 years
Days missed from work/school
Measured: Throughout the study period of approximately 5 1/2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study start12 Nov 2015
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PID)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shire Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593188
- Sponsor's protocol ID
- 161406
- Other IDs
- EUPAS21523
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2015
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
- ClinicalTrials.gov ID
- NCT02593188
- Acronym / sponsor ID
- 161406
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYQVIA- Epoch 1 | – | Biological: HYQVIAParticipants receiving HYQVIA |
| HYQVIA- Epoch 2 | – | Biological: HYQVIAParticipants with rHuPH antibody titers ≥160 (tested in Epoch 1) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYQVIAImmune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase | Biological | HYQVIA- Epoch 1, HYQVIA- Epoch 2 |
Primary outcome
Incidence of all related serious adverse events (SAEs)
Time frame: 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
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
Incidence of Infections
Time frame: 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
Treatment Regimen: Total dose administered
Time frame: 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
Treatment Administration: Actual volume per infusion
Time frame: 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
Treatment Administration: Mean rate of infusion
Time frame: 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
Treatment Administration: Number of infusion sites per infusion
Time frame: 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
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
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
Health Related Quality of Life: Treatment Preference Questionnaire
Time frame: Annually throughout the study
Health resource use: hospitalizations
Time frame: 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
Health resource use: acute care visits
Time frame: 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
Days missed from work/school
Time frame: Throughout the study period of approximately 5 1/2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shire Director study director
Shire
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases (PID), run by Baxalta now part of Shire at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of all related serious adverse events (SAEs) (time frame: Throughout the study period of approximately 5 1/2 years). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.