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

ADMA Biologics

Status: Active, not recruiting

Conditions: Primary Immune Deficiency Disorder

Treatments: Biological: Bivigam; Biological: Other

Study type: Observational

Funder types: Industry

Identifiers

NCT03037359

017

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Patients not meeting inclusion criteria

Trial design

200 participants in 2 patient groups

Bivigam

Description:

Patients with primary immunodeficiency disease treated with Bivigam™

Treatment:

Biological: Bivigam

Other IGIV

Description:

Patients with primary immunodeficiency disease treated with other IGIVs

Treatment:

Biological: Other