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

January 30, 2023 updated by: ADMA Biologics, Inc.

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with primary immunodeficiency disease treated IGIV products.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not meeting inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bivigam
Patients with primary immunodeficiency disease treated with Bivigam™
Biological: Bivigam
Human immune globulin
Other IGIV
Patients with primary immunodeficiency disease treated with other IGIVs
Biological: Other
Human immune globulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Hypotension
Time Frame: 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.
During infusion and up to 72 hours post infusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Hepatic Impairment
Time Frame: 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.
Throughout the duration of study participation, up to approximately 140 days.
Rate of Renal Impairment
Time Frame: 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.
Throughout the duration of study participation, up to approximately 140 days.
Rates of Other Adverse Events
Time Frame: 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.
Throughout the duration of study participation, up to approximately 140 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADMA Biologics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 27, 2017

First Posted (ESTIMATE)

January 31, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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