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

NCT ID: NCT03037359

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Immune Deficiency Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bivigam

Patients with primary immunodeficiency disease treated with Bivigam™

Bivigam

Intervention Type BIOLOGICAL

Human immune globulin

Other IGIV

Patients with primary immunodeficiency disease treated with other IGIVs

Other

Intervention Type BIOLOGICAL

Human immune globulin

Interventions

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Bivigam

Human immune globulin

Intervention Type BIOLOGICAL

Other

Human immune globulin

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with PID diagnosis
* Current subjects requiring treatment with an IGIV
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ADMA Biologics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Santa Barbara Specialty Pharmacy

Carpinteria, California, United States

Site Status

Allergy and Asthma of the Bay Area

Walnut Creek, California, United States

Site Status

Immunoe Research Centers

Centennial, Colorado, United States

Site Status

Central Georgia Infectious Disease Consultants

Macon, Georgia, United States

Site Status

Midwest Allergy and Sinus

Normal, Illinois, United States

Site Status

Kanarek Adult & Pediatric Allergy & Immunology

Overland Park, Kansas, United States

Site Status

Infectious Disease Consultants

Wichita, Kansas, United States

Site Status

The Center for Allergy, Asthma & Immunology

Syosset, New York, United States

Site Status

Allergy Asthma & Immunology Relief

Charlotte, North Carolina, United States

Site Status

Ohio Clinical Research Associates

Mayfield Heights, Ohio, United States

Site Status

Oklahoma Institute of Allergy and Asthma Clinical Research

Oklahoma City, Oklahoma, United States

Site Status

Austin Infectious Disease Consultants

Austin, Texas, United States

Site Status

Discovery Clinical Trials

Dallas, Texas, United States

Site Status

Allergy Partners of North Texas

Dallas, Texas, United States

Site Status

Allergy Immunology and Respiratory Care

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Irving, Texas, United States

Site Status

Lysosomal Rare Disorders Research & Treatment Center

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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017

Identifier Type: -

Identifier Source: org_study_id

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