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

Immunologic Deficiency Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783482
• Other study ID #: GC5107B_P3
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2022
• Source: GC Biopharma Corp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease (PHID).

Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy. GC5107 was administered every 21 or 28 days for a period of 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia

• Male or Female, ages 2 to 70 years

• The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study

• At least 2 documented IgG trough levels of = 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment

Exclusion Criteria:

• Subject has secondary immunodeficiency

• Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin

• Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies

• History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG

• Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction

• Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes

Intervention

Biological:
• GC5107
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton Health Sciences Corporation	Hamilton	Ontario
Canada	Queen's University - Kingston General Hospital (KGH)	Kingston	Ontario
Canada	CHU Ste-Justine - University of Montreal	Montreal	Quebec
Canada	McGill University Health Centre (MUHC) - The Montreal Children's Hospital	Montreal	Quebec
Canada	Hotel Dieu de Montreal	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Clinique Spécialisée en Allergie de la Capitale	Québec City	Quebec
Canada	Gordon Sussman Clinical Research	Toronto	Ontario
Canada	Saint Michael's Hospital	Toronto	Ontario
United States	Immuno International Research Centers	Centennial	Colorado
United States	Optimed Infusions LLC	Columbus	Ohio
United States	Allergy and Asthma Specialists	Dallas	Texas
United States	Allergy Partners of North Texas Research	Dallas	Texas
United States	Lysosomal Rare Disorder Research and Treatment Center, Inc.	Fairfax	Virginia
United States	Pediatric Pulmonary Associates of North Texas	Frisco	Texas
United States	Allergy Asthma and Immunology Clinic PA	Irving	Texas
United States	Allergy Associates of Palm Beaches PA	North Palm Beach	Florida
United States	Oklahoma Institute of Allergy Ashma and Immunology	Oklahoma City	Oklahoma
United States	Midwest Immunology Clinic and Infusion Center	Plymouth	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Green Cross Corporation	Atlantic Research Group, Parexel

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Incidence of Acute Serious Bacterial Infections (SBI)	The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis.; Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.	One year
Primary	The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product	The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107	Within 72 hours after an infusion of GC5107
Secondary	The Incidence of Infections Other Than Acute Serious Bacterial Infections		One year
Secondary	The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections	Based on the total number of days missed from work/school/kindergarten/daycare or days unable to perform normal daily activities due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.	One year
Secondary	The Number of Days of Unscheduled Physician Visits Due to Infections	Based on the total number of days of unscheduled physician visits due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.	One year
Secondary	The Number of Days of Hospitalizations Due to Infections	Subject with no experience of specific event will be included in the analysis as zero incidence, zero day, or zero time duration. The mean and SD will be calculated weighting for the duration of data available for each subject.	One year
Secondary	The Number of Days of Intravenous (IV) Therapeutic Antibiotics	Based on the total number of days of IV therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit -first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.	One year
Secondary	The Number of Days of Oral Therapeutic Antibiotics	Based on the total number of days of oral (PO) therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.	One year