Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
- Conditions
- Primary Immunodeficiency Diseases (PID)
- Interventions
- Biological: HYQVIA
- Registration Number
- NCT02593188
- Lead Sponsor
- Baxalta now part of Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 264
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HYQVIA- Epoch 1 HYQVIA Participants receiving HYQVIA HYQVIA- Epoch 2 HYQVIA Participants with rHuPH antibody titers ≥160 (tested in Epoch 1)
- Primary Outcome Measures
Name Time Method Incidence of all SAEs 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 Incidence of Infections 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 Health resource use: hospitalizations 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 Administration: Maximum infusion rate Throughout the study period of approximately 5 1/2 years 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: acute care 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 Incidence of all related serious adverse events (SAEs) 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: 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 resource use: Emergency Room visits 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 Treatment Regimen: Total dose administered 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: Duration of infusion Throughout the study period of approximately 5 1/2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
UCLA School of Medicine
🇺🇸Santa Monica, California, United States
Pikes Peak Allergy and Asthma
🇺🇸Colorado Springs, Colorado, United States
Kern Allergy Medical Clinic
🇺🇸Bakersfield, California, United States
University of California Irvine Medical Center
🇺🇸Irvine, California, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
Riviera Allergy Medical Center
🇺🇸Redondo Beach, California, United States
IMMUNOe International Research Centers
🇺🇸Thornton, Colorado, United States
Vital Prospects Clinical Research Institute, P.C.
🇺🇸Tulsa, Oklahoma, United States
National Allergy, Asthma & Urticaria Centers of Charleston, PA
🇺🇸North Charleston, South Carolina, United States
Optimed Research, LTD
🇺🇸Columbus, Ohio, United States
Allergy / Immunology Research Center of North Texas
🇺🇸Dallas, Texas, United States
Georgia Pollens Clinical Research Centers, Inc.
🇺🇸Albany, Georgia, United States
Allergy Asthma & Immunology Relief of Charlotte
🇺🇸Charlotte, North Carolina, United States
McKinney Allergy and Asthma Center
🇺🇸McKinney, Texas, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Allergy & Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Winthrop University
🇺🇸Mineola, New York, United States
Northwell Health, Inc. PRIME
🇺🇸Great Neck, New York, United States
Canton Health Center
🇺🇸Canton, Michigan, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Corning Center for Clinical Research
🇺🇸Corning, New York, United States
Greater Austin Allergy, Asthma, & Immunology
🇺🇸Round Rock, Texas, United States
Capital Allergy & Respiratory Disease Center
🇺🇸Sacramento, California, United States
Boston Childrens Hospital
🇺🇸Boston, Massachusetts, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
OK Institute of Allergy & Asthma Clinical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States