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

Sponsor

Green Cross Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02783482

Collaborator

Parexel (Industry), Atlantic Research Group (Other)

Enrollment

Locations

Arm

Actual Duration (Months)

2.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Immunologic Deficiency Syndromes	Biological: GC5107	Phase 3

Detailed Description

This will be 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 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 administered every 21 or 28 days for a period of 12 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GC5107 GC5107 Immune globulin intravenous (human) solution, 10% liquid	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) Other Names: IGIV Immune globulin intravenous (human) solution, 10% liquid

Arm

Intervention/Treatment

Experimental: GC5107

GC5107 Immune globulin intravenous (human) solution, 10% liquid

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)

Other Names:

IGIV

Immune globulin intravenous (human) solution, 10% liquid

Outcome Measures

Primary Outcome Measures

The incidence of acute serious bacterial infections [one year]
The proportion of infusions with temporally associated adverse events that occur within 72 hours following an infusion of test product [within 72 hours after treatment with test product]
The Pharmacokinetic (PK) Plasma concentration-time curve of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Area under the curve (AUC0-t, AUC0-inf) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Half life of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Volume of Distribution (Vd) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Maximum concentration (Cmax) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Minimum (trough) concentration (Cmin) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Time of maximum concentration (Tmax) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
The Pharmacokinetic (PK) Clearance (CL) of total Immunoglobulin G (IgG) [after 5th infusion (16 weeks for 28 day schedule or 12 weeks for 21 day schedule)]
Trough serum total IgG levels [one year]

Secondary Outcome Measures

The incidence of infections other than acute serious bacterial infections [one year]
The number of days missed from work/school/kindergarten/daycare, or days unable to perform normal daily activities due to infections [one year]
The number of days that the care provider of the pediatric subject had to miss work in order to care for the child [one year]
The number of days of unscheduled physician visits and hospitalizations due to infections [one year]
The number of days of intravenous (IV) or oral therapeutic antibiotics [one year]
Time to resolution of infections [one year]
The incidence of infections other than serious bacterial infections [one year]
The overall incidence of all AEs that occur during or within 1 hour, 24 hours, and 72 hours following an infusion of test product [within 72 hours after treatment with test product]
The frequency of all Adverse Events (AEs) that occur during the study [one year]
The proportion of AEs considered by the investigator to be test product related [one year]
Changes from baseline in safety parameters including vital signs, physical examinations and laboratory test [one year]
The proportion of GC5107 infusions for which the infusion rate was decreased due to AEs [one year]
Detection of changes in viral safety (freedom from transmission of blood borne virus diseases) [one year]
The Pharmacokinetic (PK) Maximum concentration (Cmax) of specific IgG antibodies [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Immuno International Research Centers	Centennial	Colorado	United States	80112
2	Allergy Associates of Palm Beaches PA	North Palm Beach	Florida	United States	33408
3	Midwest Immunology Clinic and Infusion Center	Plymouth	Minnesota	United States	55446
4	Optimed Infusions LLC	Columbus	Ohio	United States	43235
5	Oklahoma Institute of Allergy Ashma and Immunology	Oklahoma City	Oklahoma	United States	73131
6	Allergy Partners of North Texas Research	Dallas	Texas	United States	75230
7	Allergy and Asthma Specialists	Dallas	Texas	United States	75231
8	Pediatric Pulmonary Associates of North Texas	Frisco	Texas	United States	75034
9	Allergy Asthma and Immunology Clinic PA	Irving	Texas	United States	75063
10	Lysosomal Rare Disorder Research and Treatment Center, Inc.	Fairfax	Virginia	United States	22030
11	University of Alberta Hospital	Edmonton	Alberta	Canada	T6G 2V2
12	Hamilton Health Sciences Corporation	Hamilton	Ontario	Canada	L8S4K1
13	Queen's University - Kingston General Hospital (KGH)	Kingston	Ontario	Canada	K7L 2V7
14	The Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
15	Gordon Sussman Clinical Research	Toronto	Ontario	Canada	M4V 1R2
16	Saint Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
17	CHU Ste-Justine - University of Montreal	Montreal	Quebec	Canada	H3T 1C5
18	McGill University Health Centre (MUHC) - The Montreal Children's Hospital	Montreal	Quebec	Canada	H4A 3J1
19	Hotel Dieu de Montreal	Montréal	Quebec	Canada	H2W 1T8
20	Clinique Spécialisée en Allergie de la Capitale	Québec City	Quebec	Canada	G1V 4W2