A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

Primary Immune Deficiency Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03037359
• Other study ID #: 017
• Status: Active, not recruiting
• Start date: December 2016
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2023
• Source: ADMA Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with PID diagnosis

• Current subjects requiring treatment with an IGIV

Exclusion Criteria:

• Patients not meeting inclusion criteria

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency Disorder
• Primary Immunodeficiency Diseases

Intervention

Biological:
• Bivigam
Human immune globulin
• Other
Human immune globulin

Locations

Country	Name	City	State
United States	Austin Infectious Disease Consultants	Austin	Texas
United States	Santa Barbara Specialty Pharmacy	Carpinteria	California
United States	Immunoe Research Centers	Centennial	Colorado
United States	Allergy Asthma & Immunology Relief	Charlotte	North Carolina
United States	Allergy Immunology and Respiratory Care	Dallas	Texas
United States	Allergy Partners of North Texas	Dallas	Texas
United States	Discovery Clinical Trials	Dallas	Texas
United States	Lysosomal Rare Disorders Research & Treatment Center	Fairfax	Virginia
United States	University of Texas Southwestern Medical Center	Irving	Texas
United States	Central Georgia Infectious Disease Consultants	Macon	Georgia
United States	Ohio Clinical Research Associates	Mayfield Heights	Ohio
United States	Midwest Allergy and Sinus	Normal	Illinois
United States	Oklahoma Institute of Allergy and Asthma Clinical Research	Oklahoma City	Oklahoma
United States	Kanarek Adult & Pediatric Allergy & Immunology	Overland Park	Kansas
United States	The Center for Allergy, Asthma & Immunology	Syosset	New York
United States	Allergy and Asthma of the Bay Area	Walnut Creek	California
United States	Infectious Disease Consultants	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
ADMA Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of Hepatic Impairment	The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.	Throughout the duration of study participation, up to approximately 140 days.
Secondary	Rate of Renal Impairment	The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.	Throughout the duration of study participation, up to approximately 140 days.
Secondary	Rates of Other Adverse Events	The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.	Throughout the duration of study participation, up to approximately 140 days.