A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency
Information source: Grifols Therapeutics Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Immunologic Deficiency Syndrome
Intervention: Immune Globulin Intravenous (Human) (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Grifols Therapeutics Inc. Official(s) and/or principal investigator(s): Susan Sorrells, Study Director, Affiliation: Grifols Therapeutics Inc.
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Geometric Least Square Means of Area Under the Curve (AUC) for Plasma Total Immunoglobulin G (IgG)
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
Minimum age: 13 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Dr. Donald F. Stark, Inc, Vancouver, British Columbia V6H3K2, Canada
University of California, Irvine, Irvine, California 92697, United States
UCLA School of Medicine, Los Angeles, California 90095, United States
Family Allergy & Asthma Center, PC, Atlanta, Georgia 30342, United States
Allergy, Asthma & Immunology Associates, PC, Omaha, Nebraska 68124, United States
McGill University - Montreal General Hospital, Montreal, Quebec H3G1A4, Canada
Pediatric Allergy / Immunology Associates, PA, Dallas, Texas 75230, United States
Virginia Commonwealth University, Richmond, Virginia 23219, United States
Additional Information
FDA approved labeling information
Starting date: November 2006
Last updated: March 31, 2015
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