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

Status unconfirmed

Conditions studied: Primary Immune Deficiency Disorder

In brief

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.

Key facts

Study ID

NCT03037359

Run by

ADMA Biologics, Inc.

People needed

200

Starts

2016-12-01

Expected to finish

2023-06-30

Last updated by the study team

2023-02-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients not meeting inclusion criteria

Where it is running

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

Full record on ClinicalTrials.gov

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