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NCT02593188 Clinical Trial

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

Primary Immunodeficiency Diseases (PID) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02593188
Other study ID # 161406
Secondary ID EUPAS21523
Status Completed
Phase
First received
Last updated
Start date November 12, 2015
Est. completion date October 21, 2021

Study information
Verified date October 2022
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 264
Est. completion date October 21, 2021
Est. primary completion date October 21, 2021
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase

Locations
Country Name City State
United States Georgia Pollens Clinical Research Centers, Inc. Albany Georgia
United States Kern Allergy Medical Clinic Bakersfield California
United States Boston Childrens Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Canton Health Center Canton Michigan
United States Allergy Asthma & Immunology Relief of Charlotte Charlotte North Carolina
United States Carolinas Healthcare System Charlotte North Carolina
United States Asthma and Allergy Associates, PC Colorado Springs Colorado
United States Pikes Peak Allergy and Asthma Colorado Springs Colorado
United States Optimed Research, LTD Columbus Ohio
United States Corning Center for Clinical Research Corning New York
United States Allergy / Immunology Research Center of North Texas Dallas Texas
United States Northwell Health, Inc. PRIME Great Neck New York
United States Texas Children's Hospital Houston Texas
United States University of California Irvine Medical Center Irvine California
United States McKinney Allergy and Asthma Center McKinney Texas
United States Winthrop University Mineola New York
United States Columbia University Medical Center New York New York
United States National Allergy, Asthma & Urticaria Centers of Charleston, PA North Charleston South Carolina
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 Allergy & Clinical Immunology Associates Pittsburgh Pennsylvania
United States Riviera Allergy Medical Center Redondo Beach California
United States Greater Austin Allergy, Asthma, & Immunology Round Rock Texas
United States Capital Allergy & Respiratory Disease Center Sacramento California
United States Washington University Saint Louis Missouri
United States University of Utah Salt Lake City Utah
United States UCLA School of Medicine Santa Monica California
United States IMMUNOe International Research Centers Thornton Colorado
United States Vital Prospects Clinical Research Institute, P.C. Tulsa Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Baxalta now part of Shire

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of all related serious adverse events (SAEs) Throughout the study period of approximately 5 1/2 years
Primary Incidence of all SAEs Throughout the study period of approximately 5 1/2 years
Primary Incidence of non-serious adverse events (AEs), related and not related, local and systemic. Throughout the study period of approximately 5 1/2 years
Primary Incidence of Infections Throughout the study period of approximately 5 1/2 years
Primary Incidence and titer of binding and neutralizing antibodies to rHuPH20 Throughout the study period of approximately 5 1/2 years
Primary Treatment Regimen: Total dose administered Throughout the study period of approximately 5 1/2 years
Primary Treatment Regimen: Infusion interval Throughout the study period of approximately 5 1/2 years
Primary Treatment Administration: Actual volume per infusion Throughout the study period of approximately 5 1/2 years
Primary Treatment Administration: Maximum infusion rate Throughout the study period of approximately 5 1/2 years
Primary Treatment Administration: Mean rate of infusion Throughout the study period of approximately 5 1/2 years
Primary Treatment Administration: Duration of infusion Throughout the study period of approximately 5 1/2 years
Primary Treatment Administration: Number of infusion sites per infusion Throughout the study period of approximately 5 1/2 years
Primary Health Related Quality of Life: Short Form-36 (SF-36) Every 3 months in first year of study, annually for remainder of study
Primary Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire Every 3 months in first year of study, annually for remainder of study
Primary 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
Primary Health Related Quality of Life: Treatment Preference Questionnaire Annually throughout the study
Primary Health resource use: hospitalizations Throughout the study period of approximately 5 1/2 years
Primary Health resource use: length of hospital stay Throughout the study period of approximately 5 1/2 years
Primary Health resource use: acute care visits Throughout the study period of approximately 5 1/2 years
Primary Health resource use: Emergency Room visits Throughout the study period of approximately 5 1/2 years
Primary Days missed from work/school Throughout the study period of approximately 5 1/2 years
See also
  Status Clinical Trial Phase
Completed NCT03277313 - Efficacy, Safety, Tolerability, Immunogenicity and Pharmacokinetic Evaluation of HYQVIA in Pediatric PIDD Subjects Phase 3
Completed NCT03716700 - Real-world CANadian CUvitru Non-Interventional Study in Subjects Transitioning From Subcutaneous Immunoglobulin (CANCUN)
Active, not recruiting NCT05513586 - A Study to Evaluate the Long-term Safety of TAK-771 in Japanese Primary Immunodeficiency Disease (PID) Participants Phase 3
Recruiting NCT05986734 - Evaluation of Subcutaneous Immunoglobulin Product Cutaquig in Terms of Safety and Efficacy in the Treatment of Patients With Primary Immunodeficiencies
Completed NCT00546871 - Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects Phase 2/Phase 3
Recruiting NCT05755035 - A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases Phase 2/Phase 3
Completed NCT03116347 - Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects Phase 4
Completed NCT00157079 - Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders Phase 3
Completed NCT01412385 - Immune Globulin Subcutaenous (Human), 20% Phase 2/Phase 3
Completed NCT00161993 - Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia) Phase 2
Completed NCT01175213 - Tolerability and Safety of Immune Globulin Subcutaneous Solution (IGSC) and rHuPH20 in PID Phase 3
Completed NCT01218438 - Phase 2/3 Study of IGSC, 20% in PIDD Phase 2/Phase 3
Completed NCT05150340 - A Study of TAK-771 in Japanese People With Primary Immunodeficiency Diseases (PID) Phase 3
Not yet recruiting NCT06076642 - A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases Phase 3
Completed NCT00782106 - Study to Determine the Dose of Recombinant Human Hyaluronidase Needed to Infuse a Full Dose of IGIV Subcutaneously Phase 1/Phase 2
Completed NCT01485796 - Tolerability and Safety of IGI, 10% With rHuPH20 in PIDD Phase 2/Phase 3
Recruiting NCT06150534 - At-Home Subcutaneous Immunoglobulin Replacement Therapy Using Alexa Skill
Completed NCT00814320 - Gammagard Liquid and rHuPH20 in PID Phase 3
Completed NCT04346108 - A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) Phase 3

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