Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03037359
Other study ID # 017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2016
Est. completion date June 30, 2023

Study information

Verified date January 2023
Source ADMA Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigamâ„¢ 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with PID diagnosis - Current subjects requiring treatment with an IGIV Exclusion Criteria: - Patients not meeting inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Bivigam
Human immune globulin
Other
Human immune globulin

Locations

Country Name City State
United States Austin Infectious Disease Consultants Austin Texas
United States Santa Barbara Specialty Pharmacy Carpinteria California
United States Immunoe Research Centers Centennial Colorado
United States Allergy Asthma & Immunology Relief Charlotte North Carolina
United States Allergy Immunology and Respiratory Care Dallas Texas
United States Allergy Partners of North Texas Dallas Texas
United States Discovery Clinical Trials Dallas Texas
United States Lysosomal Rare Disorders Research & Treatment Center Fairfax Virginia
United States University of Texas Southwestern Medical Center Irving Texas
United States Central Georgia Infectious Disease Consultants Macon Georgia
United States Ohio Clinical Research Associates Mayfield Heights Ohio
United States Midwest Allergy and Sinus Normal Illinois
United States Oklahoma Institute of Allergy and Asthma Clinical Research Oklahoma City Oklahoma
United States Kanarek Adult & Pediatric Allergy & Immunology Overland Park Kansas
United States The Center for Allergy, Asthma & Immunology Syosset New York
United States Allergy and Asthma of the Bay Area Walnut Creek California
United States Infectious Disease Consultants Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
ADMA Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Hypotension 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 Rate of Hepatic Impairment 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.
Secondary Rate of Renal Impairment 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.
Secondary Rates of Other Adverse Events The rates of other adverse events in patients treated with Bivigamâ„¢ or other immune globulin intravenous products. Throughout the duration of study participation, up to approximately 140 days.
See also
  Status Clinical Trial Phase
Completed NCT03939533 - Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases Phase 3
Recruiting NCT03266627 - Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection Phase 2
Recruiting NCT03266640 - Virus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) Phase 2
Completed NCT01859754 - Octagam 5% Versus Comparator Post Marketing Trial
Recruiting NCT03148028 - Immunological Characteristics of Patients With PID and IBD N/A
Active, not recruiting NCT04354818 - Coronavirus (COVID-19) Outcomes Registries in Immunocompromised Individuals Australia (CORIA)
Completed NCT03988426 - Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases Phase 3
Completed NCT01888484 - Study of Octanorm Subcutaneous IG in Patients With PID Phase 3
Completed NCT01131858 - Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency Phase 1/Phase 2
Completed NCT03211689 - The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease N/A
Terminated NCT01883921 - Gamma Globulin Observations and Outcomes Database for Patients With Primary Immunodeficiency Disease (GOOD-SHEPARD-PI)
Recruiting NCT03266653 - EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection Phase 2
Completed NCT02327351 - TCR Alpha/Beta Depletion for HSCT From Haploidentical and Unrelated Donors in the Treatment of PID Phase 2/Phase 3
Completed NCT03618147 - Primary Immunodeficiency in Kuwait
Recruiting NCT04197596 - Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) Phase 1/Phase 2
Recruiting NCT03422614 - Pathophysiology of Inborn Immunodeficiencies N/A
Completed NCT02888535 - Intensive Care Unit and Secondary and Primary Immune Deficiency
Recruiting NCT04232085 - Reduced Intensity BMT for Immune Dysregulatory and Bone Marrow Failure Syndromes Using Post-Transplant Cyclophosphamide Phase 2
Completed NCT03069079 - Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study N/A
Recruiting NCT03414528 - Identification of New Inborn Errors of Immunity N/A