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Not listed No phase listed Observational

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

ClinicalTrials.gov ID: NCT03037359

Public ClinicalTrials.gov record NCT03037359. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 3:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03037359
Recruitment status
Not listed
Study type
Observational
Phase
Not listed
Lead sponsor
ADMA Biologics, Inc.
Industry
Enrollment
200 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2016 (Actual)
Primary completion
Dec 31, 2022 (Actual)
Completion
Jun 30, 2023 (Estimated)
Last update posted
Feb 1, 2023

2016 – 2023

United States locations

U.S. sites
17
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
Santa Barbara Specialty Pharmacy Carpinteria California 93013 —
Allergy and Asthma of the Bay Area Walnut Creek California 94598 —
Immunoe Research Centers Centennial Colorado 80112 —
Central Georgia Infectious Disease Consultants Macon Georgia 31201 —
Midwest Allergy and Sinus Normal Illinois 61761 —
Kanarek Adult & Pediatric Allergy & Immunology Overland Park Kansas 66211 —
Infectious Disease Consultants Wichita Kansas 67211 —
The Center for Allergy, Asthma & Immunology Syosset New York 11234 —
Allergy Asthma & Immunology Relief Charlotte North Carolina 28204 —
Ohio Clinical Research Associates Mayfield Heights Ohio 44124 —
Oklahoma Institute of Allergy and Asthma Clinical Research Oklahoma City Oklahoma 73131 —
Austin Infectious Disease Consultants Austin Texas 78705 —
Discovery Clinical Trials Dallas Texas 75225 —
Allergy Partners of North Texas Dallas Texas 75230 —
Allergy Immunology and Respiratory Care Dallas Texas 75231 —
University of Texas Southwestern Medical Center Irving Texas 75390 —
Lysosomal Rare Disorders Research & Treatment Center Fairfax Virginia 22030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03037359, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2023 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03037359 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →