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

Active, not recruiting

• Conditions: Primary Immune Deficiency Disorder
• Interventions: Biological: Other; Biological: Bivigam

• Registration Number: NCT03037359
• Lead Sponsor: ADMA Biologics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

• Patients not meeting inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Other IGIV	Other	Patients with primary immunodeficiency disease treated with other IGIVs
Bivigam	Bivigam	Patients with primary immunodeficiency disease treated with Bivigam™

Primary Outcome Measures

Name	Time	Method
Rate of Hypotension	During infusion and up to 72 hours post infusion.	The number of events of hypotension in subjects treated with Bivigam or other immune globulin intravenous (IGIV) products.; Hypotension is defined as a systolic decrease of 30mmHG or a systolic blood pressure less than 90mmHG and clinical symptoms of hypotension including 1 or more of the following: dizziness, light-headedness, fainting (syncope), chest pain, or diaphoresis.

Secondary Outcome Measures

Name	Time	Method
Rates of Other Adverse Events	Throughout the duration of study participation, up to approximately 140 days.	The rates of other adverse events in patients treated with Bivigam™ or other immune globulin intravenous products.
Rate of Hepatic Impairment	Throughout the duration of study participation, up to approximately 140 days.	The number of events of hepatic impairment in subjects treated with Bivigam or other immune globulin intravenous products. The criterion for defining hepatic impairment is transaminases three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.
Rate of Renal Impairment	Throughout the duration of study participation, up to approximately 140 days.	The number of events of renal impairment in subjects treated with Bivigam or other immune globulin intravenous. The criterion for defining hepatic impairment is creatinine values greater than three times the upper limit of normal evaluated based upon medical history, treatment history and the presence of co-morbid conditions.

Trial Locations

Locations (17)

Discovery Clinical Trials; 🇺🇸 Dallas, Texas, United States

Lysosomal Rare Disorders Research & Treatment Center; 🇺🇸 Fairfax, Virginia, United States

Allergy Asthma & Immunology Relief; 🇺🇸 Charlotte, North Carolina, United States

Midwest Allergy and Sinus; 🇺🇸 Normal, Illinois, United States

Kanarek Adult & Pediatric Allergy & Immunology; 🇺🇸 Overland Park, Kansas, United States

Allergy Partners of North Texas; 🇺🇸 Dallas, Texas, United States

The Center for Allergy, Asthma & Immunology; 🇺🇸 Syosset, New York, United States

Ohio Clinical Research Associates; 🇺🇸 Mayfield Heights, Ohio, United States

Austin Infectious Disease Consultants; 🇺🇸 Austin, Texas, United States

Allergy Immunology and Respiratory Care; 🇺🇸 Dallas, Texas, United States

Infectious Disease Consultants; 🇺🇸 Wichita, Kansas, United States

University of Texas Southwestern Medical Center; 🇺🇸 Irving, Texas, United States

Santa Barbara Specialty Pharmacy; 🇺🇸 Carpinteria, California, United States

Allergy and Asthma of the Bay Area; 🇺🇸 Walnut Creek, California, United States

Central Georgia Infectious Disease Consultants; 🇺🇸 Macon, Georgia, United States

Immunoe Research Centers; 🇺🇸 Centennial, Colorado, United States

Oklahoma Institute of Allergy and Asthma Clinical Research; 🇺🇸 Oklahoma City, Oklahoma, United States