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

Sponsor

ADMA Biologics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03037359

Collaborator

(none)

200

Enrollment

Locations

78.9

Anticipated Duration (Months)

15.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immune Deficiency Disorder	Biological: Bivigam Biological: Other

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with PID diagnosis
Current subjects requiring treatment with an IGIV

Exclusion Criteria:

Patients not meeting inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allergy and Asthma of the Bay Area	Walnut Creek	California	United States	94598
2	Immunoe Research Centers	Centennial	Colorado	United States	80112
3	Central Georgia Infectious Disease Consultants	Macon	Georgia	United States	31201
4	Midwest Allergy and Sinus	Normal	Illinois	United States	61761
5	Infectious Disease Consultants	Wichita	Kansas	United States	67211
6	Allergy Asthma & Immunology Relief	Charlotte	North Carolina	United States	28204
7	Ohio Clinical Research Associates	Mayfield Heights	Ohio	United States	44124
8	Oklahoma Institute of Allergy and Asthma Clinical Research	Oklahoma City	Oklahoma	United States	73131
9	Austin Infectious Disease Consultants	Austin	Texas	United States	78705
10	Discovery Clinical Trials	Dallas	Texas	United States	75225
11	Allergy Immunology and Respiratory Care	Dallas	Texas	United States	75231
12	University of Texas Southwestern Medical Center	Irving	Texas	United States	75390
13	Lysosomal Rare Disorders Research & Treatment Center	Fairfax	Virginia	United States	22030

Sponsors and Collaborators

ADMA Biologics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ADMA Biologics, Inc.

ClinicalTrials.gov Identifier:

NCT03037359

Other Study ID Numbers:

First Posted:

Jan 31, 2017

Last Update Posted:

Apr 11, 2022

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by ADMA Biologics, Inc.

PID

Additional relevant MeSH terms:

Primary Immunodeficiency Diseases

Immunologic Deficiency Syndromes

Immunoglobulin G

Study Results

No Results Posted as of Apr 11, 2022