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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

Page last updated: August 23, 2015

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