NCT03037359

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: ADMA Biologics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Bivigam	Human immune globulin
BIOLOGICAL	Other	Human immune globulin

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2017-01-31
• Last updated: 2023-02-01

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study