Clinical trial NCT00538915: Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immune Deficiency Disorders (PIDD)
Keywords: immunodeficiency
humoral immunity
antibody deficiency
PID
PIDD
Lead sponsor: ADMA Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-03
Enrollment: 63
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials LLC
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: Centennial
country: United States
facility: 1st Allergy and Clinical Resaerch center
state: Colorado
city: North Palm Beach
country: United States
facility: Allergy Associates of the Palm Beaches
state: Florida
city: Marietta
country: United States
facility: Marietta Pulmonary Medicine
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical center
state: Illinois
city: South Bend
country: United States
facility: South Bend Clinic LLP
state: Indiana
city: Hazard
country: United States
facility: Kentuky Lung Clinic, PSC
state: Kentucky
city: Wheaton
country: United States
facility: Institute For Allergy & Asthma
state: Maryland
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's MC
state: Missouri
city: Buffalo
country: United States
facility: Women's and Children's Hospital of Buffalo
state: New York
city: Cleveland
country: United States
facility: University Hospital Case medical center
state: Ohio
city: Dallas
country: United States
facility: Allergy/Immunology Research Center of north Texas
state: Texas
city: Dallas
country: United States
facility: AARA Research
state: Texas
city: Irving
country: United States
facility: Allergy, Asthma & Immunology Clinic, PA
state: Texas
city: Bellingham
country: United States
facility: Bellingham Asthma, Allergy Clinic
state: Washington
Study officials:
affiliation: Biotest Pharmaceuticals Corporation
name: Shailesh Chavan, M.D.
role: STUDY_DIRECTOR
References: