A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00389324
First received: October 17, 2006
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

This study will compare the blood level of Gamunex in patients. Patients will take it as an injection under the skin or in a vein. The study will compare how safe and tolerable the two methods are in the patients. The patients in this study have a defect in their immune system from a genetic cause.


Condition Intervention Phase
Immunologic Deficiency Syndrome
Biological: Immune Globulin Intravenous (Human)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Single-Sequence, Crossover Trial to Evaluate the Pharmacokinetics and Safety of Subcutaneous Gamunex® 10% (Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified) in Subjects With Primary Immunodeficiency

Resource links provided by NLM:


Further study details as provided by Grifols Therapeutics Inc.:

Primary Outcome Measures:
  • Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG) [ Time Frame: IV Phase (21 or 28 days) at IV Visit #1, pre- and post-dose: 0 hr., 1 hr., and 1, 2, 3, 5, 7, 14, 21, and 28 days; SC Phase at Week #17, pre- and post-dose: 0 hr., and 1, 3, 4, 5, and 7 days ] [ Designated as safety issue: No ]
    Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).


Enrollment: 32
Study Start Date: November 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immune Globulin Intravenous (Human)
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Biological: Immune Globulin Intravenous (Human)
This trial was an open-label, single-sequence, study. The enrolled subjects received IGIV-C via two routes of administration (IV for 4 -5 weeks and SC for 24 weeks) in order to compare the PK variables, safety and tolerability of SC administration of IGIV-C. Certain subjects required IV IGIV-C dosing during a Run-in Phase (3 - 4 months) for steady-state conditions prior to the IV phase. Subjects received two IV infusions of IGIV (between 200 - 600 mg based on the subject's previous IgG dosing regimen, 3 to 4 weeks apart) until a steady-state was reached at which time PK profiling was performed. Subjects began weekly SC administration (1.37 times the weekly equivalency of each subject's monthly IV dose) 1 week following last IV dose and followed for a period of six months.
Other Names:
  • Gamunex
  • Gaminex
  • Immune globulin intravenous (Human)(IGIV)
  • BAY 41-1000
  • TAL-05-00004
  • IGIV-C
  • IVIG
  • IGIVnex
  • NDC-13353-645-71
  • NDC-13353-646-24
  • NDC-13353-645-12
  • NDC-13353-645-15
  • NDC-13353-645-2

Detailed Description:

This is an open-label, single-sequence, multi-center trial with subjects previously diagnosed with primary immune deficiency. Subjects will be on IGIV until a steady state is reached at which time PK profiling during the IV phase will occur. Subjects will begin SC administration 1 week following last IV dose and followed for a period of six months. PK profiling in SC phase will occur when subject reaches approximate steady-state on SC administration.

  Eligibility

Ages Eligible for Study:   13 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults and adolescents (age 13-75 inclusive) with a documented and confirmed pre-existing diagnosis of chronic primary immunodeficiency
  • Previously or currently on IgG replacement therapy
  • Documented (within 3 months) plasma IgG level of ≥500 mg/dL on current IgG therapy (IgG level can be obtained at the screening visit if documentation is not available)
  • The medical records for all subjects within the previous 2 years should be available to document previous infections and treatment

Exclusion Criteria:

  • Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial
  • The subject has a known adverse reaction to Gamunex or other blood products
  • The subject has a history of blistering skin disease, clinically significant thrombocytopenia, bleeding disorder, diffuse rash, recurrent skin infections or other disorders where subcutaneous therapy would be contraindicated
  • The subject has known selective IgA deficiency with the exception of a known selective IgA deficient subject who has no previous documented eventful reaction to products containing IgA
  • The subject is pregnant or lactating
  • The subject has significant proteinuria and/or has a history of acute renal failure and/or severe renal impairment (BUN or creatinine more than 2.5 times the upper limit of normal) and/or on dialysis
  • The subject has known substance or prescription drug abuse in the past 12 months
  • The subject has a history of or current diagnosis of deep venous thrombosis
  • The subject has an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000 x 10e6/L), or HIV infection/AIDS
  • The subject is receiving any of the following medications: corticosteroids (long-term daily, >1 mg of prednisone equivalent/kg/day for >30 days) (intermittent courses would not exclude subject); immunosuppressants; or immunomodulators
  • The subject has non-controlled arterial hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg)
  • The subject has anemia (hemoglobin <10 g/dL) at screening
  • The subject has participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational blood product within the previous 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389324

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697
UCLA School of Medicine
Los Angeles, California, United States, 90095
United States, Georgia
Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States, 30342
United States, Nebraska
Allergy, Asthma & Immunology Associates, PC
Omaha, Nebraska, United States, 68124
United States, Texas
Pediatric Allergy / Immunology Associates, PA
Dallas, Texas, United States, 75230
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Canada, British Columbia
Dr. Donald F. Stark, Inc
Vancouver, British Columbia, Canada, V6H3K2
Canada, Quebec
McGill University - Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
Grifols Therapeutics Inc.
Investigators
Study Director: Susan Sorrells Grifols Therapeutics Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Grifols Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00389324     History of Changes
Other Study ID Numbers: 060001
Study First Received: October 17, 2006
Results First Received: July 30, 2009
Last Updated: November 9, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Grifols Therapeutics Inc.:
Primary immune deficiency

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

ClinicalTrials.gov processed this record on April 16, 2014