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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03037359
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Primary Immune Deficiency Disorder Biological: Bivigam Biological: Other

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Study Type : Observational [Patient Registry]
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
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 : December 2016
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary immunodeficiency disease treated IGIV products.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients not meeting inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037359


Locations
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United States, Colorado
Immuneo Research Centers
Centennial, Colorado, United States, 80112
United States, North Carolina
Allergy Asthma & Immunology Relief
Charlotte, North Carolina, United States, 28204
United States, Ohio
Ohio Clinical Research Associates
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Oklahoma Institute of Allergy and Asthma Clinical Research
Oklahoma City, Oklahoma, United States, 73131
United States, Texas
Discovery Clinical Trials
Dallas, Texas, United States, 75225
United States, Virginia
Lysosomal Rare Disorders Research & Treatment Center
Fairfax, Virginia, United States, 22030
Sponsors and Collaborators
ADMA Biologics, Inc.
Additional Information:

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Responsible Party: ADMA Biologics, Inc.
ClinicalTrials.gov Identifier: NCT03037359    
Other Study ID Numbers: 017
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by ADMA Biologics, Inc.:
PID
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs