Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

Status Completed

Clinical Trial Summary

Phase 3 multicenter, open-label study of safety, tolerability, efficacy, and pharmacokinetics (PK) of ProMetic's Immune Globulin Intravenous (Human) 10%, the investigational medicinal product [IMP]), in Adults and Children with Primary Immunodeficiency Diseases (PIDD).

Clinical Trial Description

This is a pivotal Phase 3, open-label, single-arm, multicenter study to assess the tolerability, safety, efficacy, and Pharmacokinetics of the Investigational Medicinal Product in adults and children with Primary Immunodeficiency Diseases (PIDD). A total of approximately 75 subjects aged 2-80 years will be enrolled in the study. Subjects who switch from an investigational immune globulin or subcutaneous immune globulin (IGSC) are required to receive a stable dose of commercial product (CP), which is a licensed commercially available immune globulin intravenous (IGIV) product for at least 3 cycles before they can be given the Investigational Medicinal Product . This study schema will result in the Commercial Product Treatment Period and Investigational Medicinal Product Treatment Period. All subjects will be treated on an outpatient basis with the Investigational Medicinal Product for approximately 1 year, with the dose and schedule based on their previous IGIV treatment regimen (21-day or 28-day dosing interval). A subset of subjects will participate in a Pharmacokinetics sub-study. The primary objective of the study is to examine the rate of clinically documented serious bacterial infections (SBIs) in subjects treated with the Investigational Medicinal Product to achieve a rate of less than one SBI per year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02269163
Study type	Interventional
Source	Prometic Biotherapeutics, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	January 26, 2016
Completion date	January 11, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04561115` - A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency	Phase 3
Recruiting	`NCT06355323` - Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France	N/A
Completed	`NCT04566692` - A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency	Phase 4
Completed	`NCT01465958` - Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency	Phase 4
Completed	`NCT01581593` - Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)	Phase 3
Completed	`NCT02881437` - IgG Level in Primary Immunodeficiency Switching From Standard SCIG to Every Other Week HyQvia	Phase 4
Recruiting	`NCT06092528` - Investigation of the Effects of Pulmonary Rehabilitation in Children With Primary Immunodeficiency	N/A
Active, not recruiting	`NCT03576742` - Severe Immune Cytopenia Registry Www.Sic-reg.Org
Completed	`NCT03907241` - CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL	Phase 3
Not yet recruiting	`NCT04902807` - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Completed	`NCT02806986` - Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency	Phase 3
Completed	`NCT03339778` - The Benefit of 5% IVIG for Patients With Primary Immunodeficiency Disorders Who Experience Adverse Events on 10% IVIG Preparations	N/A
Enrolling by invitation	`NCT00895271` - Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Recruiting	`NCT03206099` - NIAID Centralized Sequencing Protocol
Completed	`NCT02503293` - A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push	Phase 4
Recruiting	`NCT03610802` - Send-In Sample Collection to Achieve Genetic and Immunologic Characterization of Primary Immunodeficiencies
Completed	`NCT03815357` - What is the Incidence of an Immune Disorder in Children With Invasive Pneumococcal Disease (IPD)?
Terminated	`NCT03733249` - Long Term Follow-up Study for Patients Enrolled on the BP-004 Clinical Study	Phase 1/Phase 2
Not yet recruiting	`NCT02123615` - ASIS for GAMMAGARD in Primary Immunodeficiency	Phase 1/Phase 2
Completed	`NCT02604810` - Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency	Phase 3