A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
A Multicenter, Non-interventional, Observational, Prospective Study to Assess Hypotension in Patients With Primary Immunodeficiency Disease Treated With Bivigam™ (Human 10%) or Other Commercial Human 10% Immune Globulin (Intravenous) (IGIV) Products During Infusion and up to 72 Hours Post Infusion
1 other identifier
observational
200
1 country
17
Brief Summary
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions. No study medication will be provided to subjects in this study. Study physicians will make all treatment decisions according to their usual practice and will provide prescriptions for his/her subjects, as appropriate. The only addition is the collection and structured documentation of data generated through usual practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 20, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFebruary 1, 2023
January 1, 2023
6.1 years
January 20, 2017
January 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Hypotension
The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products. Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.
During infusion and up to 72 hours post infusion.
Secondary Outcomes (3)
Rate of Hepatic Impairment
Throughout the duration of study participation, up to approximately 140 days.
Rate of Renal Impairment
Throughout the duration of study participation, up to approximately 140 days.
Rates of Other Adverse Events
Throughout the duration of study participation, up to approximately 140 days.
Study Arms (2)
Bivigam
Patients with primary immunodeficiency disease treated with Bivigam™
Other IGIV
Patients with primary immunodeficiency disease treated with other IGIVs
Interventions
Eligibility Criteria
Patients with primary immunodeficiency disease treated IGIV products.
You may qualify if:
- Patients with PID diagnosis
- Current subjects requiring treatment with an IGIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Santa Barbara Specialty Pharmacy
Carpinteria, California, 93013, United States
Allergy and Asthma of the Bay Area
Walnut Creek, California, 94598, United States
Immunoe Research Centers
Centennial, Colorado, 80112, United States
Central Georgia Infectious Disease Consultants
Macon, Georgia, 31201, United States
Midwest Allergy and Sinus
Normal, Illinois, 61761, United States
Kanarek Adult & Pediatric Allergy & Immunology
Overland Park, Kansas, 66211, United States
Infectious Disease Consultants
Wichita, Kansas, 67211, United States
The Center for Allergy, Asthma & Immunology
Syosset, New York, 11234, United States
Allergy Asthma & Immunology Relief
Charlotte, North Carolina, 28204, United States
Ohio Clinical Research Associates
Mayfield Heights, Ohio, 44124, United States
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, 73131, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
Discovery Clinical Trials
Dallas, Texas, 75225, United States
Allergy Partners of North Texas
Dallas, Texas, 75230, United States
Allergy Immunology and Respiratory Care
Dallas, Texas, 75231, United States
University of Texas Southwestern Medical Center
Irving, Texas, 75390, United States
Lysosomal Rare Disorders Research & Treatment Center
Fairfax, Virginia, 22030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2017
First Posted
January 31, 2017
Study Start
December 1, 2016
Primary Completion
December 31, 2022
Study Completion
June 30, 2023
Last Updated
February 1, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share