Clinical trial NCT02593188: Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Official title: Non-Interventional Post-Marketing Safety Study on the Long-Term Safety of HYQVIA (Global)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immunodeficiency Diseases (PID)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-11-01
Enrollment: 264
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of all related serious adverse events (SAEs)
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Incidence of all SAEs
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Incidence of non-serious adverse events (AEs), related and not related, local and systemic.
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Incidence of Infections
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Incidence and titer of binding and neutralizing antibodies to rHuPH20
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Regimen: Total dose administered
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Regimen: Infusion interval
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Administration: Actual volume per infusion
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Administration: Maximum infusion rate
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Administration: Mean rate of infusion
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Administration: Duration of infusion
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Treatment Administration: Number of infusion sites per infusion
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Health Related Quality of Life: Short Form-36 (SF-36)
timeFrame: Every 3 months in first year of study, annually for remainder of study
measure: Health Related Quality of Life: EuroQol 5-Dimension (EQ-5D) Questionnaire
timeFrame: Every 3 months in first year of study, annually for remainder of study
measure: Health Related Quality of Life: Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
timeFrame: Every 3 months in first year of study, annually for remainder of study
measure: Health Related Quality of Life: Treatment Preference Questionnaire
timeFrame: Annually throughout the study
measure: Health resource use: hospitalizations
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Health resource use: length of hospital stay
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Health resource use: acute care visits
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Health resource use: Emergency Room visits
timeFrame: Throughout the study period of approximately 5 1/2 years
measure: Days missed from work/school
timeFrame: Throughout the study period of approximately 5 1/2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Kern Allergy Medical Clinic
state: California
city: Irvine
country: United States
facility: University of California Irvine Medical Center
state: California
city: Redondo Beach
country: United States
facility: Riviera Allergy Medical Center
state: California
city: Sacramento
country: United States
facility: Capital Allergy & Respiratory Disease Center
state: California
city: Santa Monica
country: United States
facility: UCLA School of Medicine
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates, PC
state: Colorado
city: Colorado Springs
country: United States
facility: Pikes Peak Allergy and Asthma
state: Colorado
city: Thornton
country: United States
facility: IMMUNOe International Research Centers
state: Colorado
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers, Inc.
state: Georgia
city: Boston
country: United States
facility: Boston Childrens Hospital
state: Massachusetts
city: Canton
country: United States
facility: Canton Health Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Corning
country: United States
facility: Corning Center for Clinical Research
state: New York
city: Great Neck
country: United States
facility: Northwell Health, Inc. PRIME
state: New York
city: Mineola
country: United States
facility: Winthrop University
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Charlotte
country: United States
facility: Allergy Asthma & Immunology Relief of Charlotte
state: North Carolina
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: OK Institute of Allergy & Asthma Clinical Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates
state: Pennsylvania
city: North Charleston
country: United States
facility: National Allergy, Asthma & Urticaria Centers of Charleston, PA
state: South Carolina
city: Dallas
country: United States
facility: Allergy / Immunology Research Center of North Texas
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: McKinney
country: United States
facility: McKinney Allergy and Asthma Center
state: Texas
city: Round Rock
country: United States
facility: Greater Austin Allergy, Asthma, & Immunology
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Shire
name: Shire Director
role: STUDY_DIRECTOR
References: