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

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ClinicalTrials.gov Identifier: NCT02783482
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : November 22, 2017
Sponsor:
Collaborators:
Parexel
Atlantic Research Group
Information provided by (Responsible Party):
Green Cross Corporation

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : June 2016
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine


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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783482


Contacts
Contact: Ahmi Woo 82 31 260 9467 ahmi.woo@greencross.com

Locations
United States, Colorado
Immuno International Research Centers Recruiting
Centennial, Colorado, United States, 80112
Contact: Issac Melamed, M.D         
Principal Investigator: Issac Melamed, M.D         
United States, Florida
Allergy Associates of Palm Beaches PA Recruiting
North Palm Beach, Florida, United States, 33408
Contact: Mark Stein, M.D         
Principal Investigator: Mark Stein, M.D         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: James Moy, M.D         
Principal Investigator: James Moy, M.D         
United States, Minnesota
Midwest Immunology Clinic and Infusion Center Recruiting
Plymouth, Minnesota, United States, 55446
Contact: Ralph Shapiro, M.D         
Principal Investigator: Ralph Shapiro, M.D         
United States, Ohio
Optimed Infusions LLC Recruiting
Columbus, Ohio, United States, 43235
Contact: Donald McNeil, M.D         
Principal Investigator: Donald McNeil, M.D         
United States, Oklahoma
Oklahoma Institute of Allergy Ashma and Immunology Recruiting
Oklahoma City, Oklahoma, United States, 73131
Contact: Amy Darter, M.D         
Principal Investigator: Amy Darter, M.D         
United States, Texas
Allergy Partners of North Texas Research Recruiting
Dallas, Texas, United States, 75230
Contact: Richard Wasserman, M.D         
Principal Investigator: Richard Wasserman, M.D         
Allergy and Asthma Specialists Recruiting
Dallas, Texas, United States, 75231
Contact: William Lumry, M.D         
Principal Investigator: William Lumry, M.D         
Allergy Asthma and Immunology Clinic PA Recruiting
Irving, Texas, United States, 75063
Contact: Daniel Suez, M.D         
Principal Investigator: Daniel Suez, M.D         
United States, Virginia
Lysosomal Rare Disorder Research and Treatment Center, Inc. Recruiting
Fairfax, Virginia, United States, 22030
Contact: Oral Alpan, M.D         
Principal Investigator: Oral Alpan, M.D         
Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2V2
Contact: Bruce Ritchie, M.D         
Principal Investigator: Bruce Ritchie, M.D         
Canada, Ontario
Hamilton Health Sciences Corporation Recruiting
Hamilton, Ontario, Canada, L8S4K1
Contact: Paul Keith, M.D         
Principal Investigator: Paul Keith, M.D         
Queen's University - Kingston General Hospital (KGH) Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Anne Ellis    (613) 548-2336      
Principal Investigator: Anne Ellis         
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Juthaporn Cowan, M.D         
Principal Investigator: Juthaporn Cowan, M.D         
Gordon Sussman Clinical Research Recruiting
Toronto, Ontario, Canada, M4V 1R2
Contact: Gordon Sussman, M.D         
Principal Investigator: Gordon Sussman, M.D         
Saint Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Stephen Betschel, M.D         
Principal Investigator: Stephen Betschel         
Canada, Quebec
CHU Ste-Justine - University of Montreal Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Elie Haddad    (514) 345-4713      
Principal Investigator: Elie Haddad         
McGill University Health Centre (MUHC) - The Montreal Children's Hospital Recruiting
Montreal, Quebec, Canada, H4A 3J1
Contact: Bruce Mazer    (514) 934-1934      
Principal Investigator: Bruce Mazer         
Hotel Dieu de Montreal Not yet recruiting
Montréal, Quebec, Canada, H2W 1T8
Contact: Hugo Chapdelaine, M.D         
Principal Investigator: Hugo Chapdelaine, M.D         
Clinique Spécialisée en Allergie de la Capitale Recruiting
Québec City, Quebec, Canada, G1V 4W2
Contact: Jacques Hébert    (418) 659-7741      
Principal Investigator: Jacques Hébert         
Sponsors and Collaborators
Green Cross Corporation
Parexel
Atlantic Research Group

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02783482     History of Changes
Other Study ID Numbers: GC5107B_P3
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs