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

NCT00389324 | Completed Phase 2 Results

• 1 other identifier: 060001
• Study Type: interventional
• Target: 35
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Immunologic Deficiency Syndrome

Keywords

Primary immune deficiency

Outcome Measures

Primary Outcomes (1)

• Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)

  Geometric least-squares mean of steady-state plasma concentration of total IgG vs. time profile (AUC).

  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

Study Arms (1)

Immune Globulin Intravenous (Human)

EXPERIMENTAL

Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified

Biological: Immune Globulin Intravenous (Human)

Interventions

Immune Globulin Intravenous (Human) BIOLOGICAL

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.

Also known as: 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

Immune Globulin Intravenous (Human)

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (8)

University of California, Irvine

Irvine, California, 92697, United States

Location

UCLA School of Medicine

Los Angeles, California, 90095, United States

Location

Family Allergy & Asthma Center, PC

Atlanta, Georgia, 30342, United States

Location

Allergy, Asthma & Immunology Associates, PC

Omaha, Nebraska, 68124, United States

Location

Pediatric Allergy / Immunology Associates, PA

Dallas, Texas, 75230, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Dr. Donald F. Stark, Inc

Vancouver, British Columbia, V6H3K2, Canada

Location

McGill University - Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Related Links

• FDA approved labeling information

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Immune System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Henry Li, PhD
• Organization: Grifols Therapeutics, Inc.

henry.li@grifols.com

800-520-2807

Study Officials

• Susan Sorrells

  Grifols Therapeutics LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2006
• First Posted: October 18, 2006
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 20, 2015
• Results First Posted: December 18, 2012

Record last verified: 2015-03

Locations

CA (2); US (6)