Clinical trial NCT02783482: Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunologic Deficiency Syndromes
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
Collaborators: name: Parexel
name: Atlantic Research Group
First posted: 2016-05-26
Enrollment: 49
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Incidence of Acute Serious Bacterial Infections (SBI)
timeFrame: One year
measure: The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product
timeFrame: Within 72 hours after an infusion of GC5107
Secondary outcomes:
measure: The Incidence of Infections Other Than Acute Serious Bacterial Infections
timeFrame: One year
measure: The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections
timeFrame: One year
measure: The Number of Days of Unscheduled Physician Visits Due to Infections
timeFrame: One year
measure: The Number of Days of Hospitalizations Due to Infections
timeFrame: One year
measure: The Number of Days of Intravenous (IV) Therapeutic Antibiotics
timeFrame: One year
measure: The Number of Days of Oral Therapeutic Antibiotics
timeFrame: One year
Other outcomes:
Locations:
city: Centennial
country: United States
facility: Immuno International Research Centers
state: Colorado
city: North Palm Beach
country: United States
facility: Allergy Associates of Palm Beaches PA
state: Florida
city: Plymouth
country: United States
facility: Midwest Immunology Clinic and Infusion Center
state: Minnesota
city: Columbus
country: United States
facility: Optimed Infusions LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy Ashma and Immunology
state: Oklahoma
city: Dallas
country: United States
facility: Allergy Partners of North Texas Research
state: Texas
city: Dallas
country: United States
facility: Allergy and Asthma Specialists
state: Texas
city: Frisco
country: United States
facility: Pediatric Pulmonary Associates of North Texas
state: Texas
city: Irving
country: United States
facility: Allergy Asthma and Immunology Clinic PA
state: Texas
city: Fairfax
country: United States
facility: Lysosomal Rare Disorder Research and Treatment Center, Inc.
state: Virginia
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation
state: Ontario
city: Kingston
country: Canada
facility: Queen's University - Kingston General Hospital (KGH)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Gordon Sussman Clinical Research
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Montreal
country: Canada
facility: CHU Ste-Justine - University of Montreal
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC) - The Montreal Children's Hospital
state: Quebec
city: Montréal
country: Canada
facility: Hotel Dieu de Montreal
state: Quebec
city: Québec City
country: Canada
facility: Clinique Spécialisée en Allergie de la Capitale
state: Quebec
Study officials:
References:
citation: Perez EE, Hebert J, Ellis AK, Alpan O, Lumry WR, Shapiro R, Suez D, Mandujano JF, Wasserman RL. Efficacy, Safety and Tolerability of a New 10% Intravenous Immunoglobulin for the Treatment of Primary Immunodeficiencies. Front Immunol. 2021 Jul 8;12:707463. doi: 10.3389/fimmu.2021.707463. eCollection 2021.