Clinical trial NCT03037359: A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Immune Deficiency Disorder
Keywords: PID
Lead sponsor: ADMA Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary immunodeficiency disease treated IGIV products.

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.


Eligibility criteria: Inclusion Criteria:

* Patients with PID diagnosis
* Current subjects requiring treatment with an IGIV

Exclusion Criteria:

* Patients not meeting inclusion criteria

Primary outcomes:
measure: Rate of Hypotension
timeFrame: During infusion and up to 72 hours post infusion.
Secondary outcomes:
measure: Rate of Hepatic Impairment
timeFrame: Throughout the duration of study participation, up to approximately 140 days.
measure: Rate of Renal Impairment
timeFrame: Throughout the duration of study participation, up to approximately 140 days.
measure: Rates of Other Adverse Events
timeFrame: Throughout the duration of study participation, up to approximately 140 days.
Other outcomes:
Locations:
city: Carpinteria
country: United States
facility: Santa Barbara Specialty Pharmacy
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma of the Bay Area
state: California
city: Centennial
country: United States
facility: Immunoe Research Centers
state: Colorado
city: Macon
country: United States
facility: Central Georgia Infectious Disease Consultants
state: Georgia
city: Normal
country: United States
facility: Midwest Allergy and Sinus
state: Illinois
city: Overland Park
country: United States
facility: Kanarek Adult & Pediatric Allergy & Immunology
state: Kansas
city: Wichita
country: United States
facility: Infectious Disease Consultants
state: Kansas
city: Syosset
country: United States
facility: The Center for Allergy, Asthma & Immunology
state: New York
city: Charlotte
country: United States
facility: Allergy Asthma & Immunology Relief
state: North Carolina
city: Mayfield Heights
country: United States
facility: Ohio Clinical Research Associates
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical Research
state: Oklahoma
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Dallas
country: United States
facility: Discovery Clinical Trials
state: Texas
city: Dallas
country: United States
facility: Allergy Partners of North Texas
state: Texas
city: Dallas
country: United States
facility: Allergy Immunology and Respiratory Care
state: Texas
city: Irving
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fairfax
country: United States
facility: Lysosomal Rare Disorders Research & Treatment Center
state: Virginia
Study officials:
References: