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Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Information source: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immune Deficiency Disorders (PIDD)

Intervention: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%] (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Biotest Pharmaceuticals Corporation

Official(s) and/or principal investigator(s):
Shailesh Chavan, M.D., Study Director, Affiliation: Biotest Pharmaceuticals Corporation


The purpose of this study is to determine if NABI-IGIV (10%) [Immune Globulin Intravenous (Human), 10%] is safe and effective in preventing serious bacterial infections (SBIs) in the treatment of patients with primary immune deficiency disorders (PIDD) when compared to historical control data.

Clinical Details

Official title: Open Label, Phase III Safety, Efficacy, and Pharmacokinetic Study of NABI-IGIV 10% [Immune Globulin Intravenous (Human), 10%] in Subjects With Primary Immune Deficiency Disorders (PIDD)

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To Assess the Efficacy of Nabi-IGIV 10% in Preventing Serious Bacterial Infections (SBIs) Compared to Historical Control Data [Per US Food and Drug Administration (FDA) Requirements by Demonstration of a Serious Infection Rate Per Person Year of <1.0].


Minimum age: 6 Years. Maximum age: 75 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female, age ≥ 6 and ≤ 75, with a documented and confirmed pre-existing

diagnosis of chronic primary immune deficiency (PIDD) with a low total immunoglobulin G (IgG) level and deficient antibody production before chronic therapy (i. e., X-linked agammaglobulinemia, common variable immunodeficiency (CVID), Hyper IgM Syndrome with immunoglobulin G (IgG) deficiency, etc).

- Currently on immune globulin intravenous (IGIV) replacement therapy at a fixed

interval and dosage with a total monthly dose of immune globulin intravenous (IGIV) between 300 and 800 mg/kg that has been stable for at least 3 months prior to screening.

- Documented (within 3 months) plasma immunoglobulin G (IgG) trough level of >500 mg/dL

on current immunoglobulin G (IgG) therapy [immunoglobulin G (IgG) levels may be obtained at screening if previous results not available].

- Medical records documenting infections and treatment within the previous 2 years need

to be available for review.

- Subject or legal guardian(s) must have given written informed consent/assent.

- If a menstruating female, have a negative serum or urine pregnancy test within 7

days prior to the first dose of Nabi-IGIV [immune globulin intravenous (Human) 10%] and agree to use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile. Exclusion Criteria:

- Received any blood product [other than immune globulin intravenous (IGIV)] within the

last 3 months prior to screening or received any investigational agent [other than immune globulin intravenous (IGIV)] within the last four weeks prior to receiving Nabi-IGIV [immune globulin intravenous (Human) 10%].

- Known history of medically significant adverse reactions to other immunoglobulin G

(IgG) or blood products.

- Known selective immunoglobulin A (IgA) deficiency, history of allergic reaction to

products containing immunoglobulin A (IgA) or has a history of antibodies to immunoglobulin A (IgA).

- Known significant proteinuria and/or has a history of acute renal failure/or severe

renal impairment [blood urea nitrogen (BUN) or creatinine more than 1. 5 times the upper limit of normal].

- Known history or current diagnosis of deep venous thrombosis.

- Known medical condition that is known to cause secondary immune deficiency, such as

chronic lymphocytic leukemia, lymphoma, multiple myeloma, human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), or chronic or recurrent neutropenia (absolute neutrophil count less than 500 mm3).

- Current daily use of corticosteroids (> 10 mg of prednisone equivalent /day for > 30

days), immunosuppressants or immunomodulators. (Intermittent corticosteroid use during the study is allowable, if medically necessary.)

- Known non-controllable arterial hypertension (systolic blood pressure (BP) > 160 mmHg

and /or diastolic BP >100 mmHg.)

- Known anemia at screening (hemoglobin <10 g/dL).

- Subject is pregnant or lactating.

- Known history of illicit drug use within 3 months prior to the administration of the

investigational product and for the study duration.

- Have any condition judged by the study physician to preclude participation in the

study, including any psychological disorder, which might hinder compliance.

- Known active viral or bacterial infection or symptoms/signs consistent with such an

infection within the two weeks prior to the initial dose of investigational product infusion. Subjects may be on antibiotics as long as signs/symptoms of infection have been absent for two weeks prior to the initial infusion of investigational product (IP).

- Expectation of non-compliance with the protocol procedures and visit schedule.

Locations and Contacts

University of Alabama, Birmingham, Alabama 35294, United States

Precision Trials LLC, Phoenix, Arizona 85032, United States

Children's Hospital of Los Angeles, Los Angeles, California 90027, United States

1st Allergy and Clinical Resaerch center, Centennial, Colorado 80112, United States

Allergy Associates of the Palm Beaches, North Palm Beach, Florida 33408, United States

Marietta Pulmonary Medicine, Marietta, Georgia 30060, United States

Rush University Medical center, Chicago, Illinois 60612, United States

South Bend Clinic LLP, South Bend, Indiana 46617, United States

Kentuky Lung Clinic, PSC, Hazard, Kentucky 41701, United States

Institute For Allergy & Asthma, Wheaton, Maryland 20902, United States

Cardinal Glennon Children's MC, Saint Louis, Missouri 63104, United States

Women's and Children's Hospital of Buffalo, Buffalo, New York 14222, United States

University Hospital Case medical center, Ciere, Ohio 44103, United States

AARA Research, Dallas, Texas 75231, United States

Allergy/Immunology Research Center of north Texas, Dallas, Texas 75230, United States

Allergy, Asthma & Immunology Clinic, PA, Irving, Texas 75063, United States

Bellingham Asthma, Allergy Clinic, Bellingham, Washington 98225, United States

Additional Information

Starting date: September 2007
Last updated: February 23, 2012

Page last updated: August 23, 2015

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