Clinical Trials Logo
  1. Home
  2. Primary Immune Deficiency
  3. NCT04565015

Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Primary Immune Deficiency Clinical Trial

Official title:
An Open-Label, Single-Arm, Historically Controlled, Prospective, Multi-Center Phase III Study to Evaluate the Pharmacokinetics and Safety of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects with Primary Humoral Immunodeficiency (PHID).

Clinical Trial Description

This is a prospective, open-label, single-arm, historically controlled, multi-center Phase III study to assess the pharmacokinetics and safety of Immune Globulin Intravenous (Human) GC5107 in pediatric subjects aged ≥ 2 years and < 17 years with PHID. Subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IGIV) maintenance therapy. GC5107 will be infused every 21 or 28 days for a period of 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04565015
Study type Interventional
Source GC Biopharma Corp
Contact Hyejoo Kim
Phone +82-31-260-9192
Email hyejoo.kim@gccorp.com
Status Recruiting
Phase Phase 3
Start date December 21, 2020
Completion date November 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05321407 - COVID-19 Vaccine Responses in PIDD Subjects
Completed NCT01199705 - Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) Phase 3
Recruiting NCT05070455 - An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD) Phase 4
Recruiting NCT03836690 - Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation Phase 1
Completed NCT01461018 - Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) Phase 3
Completed NCT04581460 - Primitive Immunodeficiency and Pregnancy
Recruiting NCT05476653 - A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID) . N/A
Completed NCT00419341 - Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy Phase 3
Active, not recruiting NCT02868333 - Determinants of Health Status and Quality of Life in Patients With Primary Immunodeficiencies Inhereted Diagnosed During Childhood N/A
Completed NCT01166074 - Retrospective Chart Review of Subcutaneous IgG Use in Infants N/A
Recruiting NCT05932316 - Evaluating Bronchodilator Response in Patients With Bronchiectasis N/A
Recruiting NCT04784364 - Biologics And Clinical Immunology Cohort at Sinai
Completed NCT06014463 - Evaluation of Adult Patients With Immunodeficiency Within the Scope of the ICF
Recruiting NCT04459689 - COVID-19 in PID Survey
Completed NCT02711228 - Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules Phase 4
Recruiting NCT04919018 - Characterizing the Upper Airway Manifestations in Primary Ciliary Dyskinesia and Primary Immunodeficiencies
Completed NCT00719680 - Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID) Phase 3
Terminated NCT00023504 - Antibody Production in Immune Disorders Phase 4
Recruiting NCT00246857 - Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death
Recruiting NCT04702243 - Defining the Genetic Etiology of Suppurative Lung Disease in Children and Adults