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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00538915
First received: October 1, 2007
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Primary Immune Deficiency Disorders (PIDD)
Biological: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Biotest Pharmaceuticals Corporation:

Primary Outcome Measures:
  • 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]. [ Time Frame: One year ] [ Designated as safety issue: No ]
    The primary efficacy parameter was the serious bacterial infections (SBIs) rate per person-years compared to historical control data [as determined by requirements established by the US Food and Drug Administration (FDA) by demonstration of a serious infection rate per person year of <1.0]. The infections included bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.


Enrollment: 63
Study Start Date: September 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nabi-IGIV Infused Every 3- or 4-Weeks Biological: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] is a clear or slightly opalescent, colorless to pale yellow sterile solution of 10% protein concentration of immunoglobulin G (100mg/mL). It is packaged as 5g in 50mL solution and 10g in 100mL solution. Dosing will be 300-800 mg/kg based on subject's prior dosing history. Infusions will be every 3 or 4 weeks.

  Eligibility

Ages Eligible for Study:   6 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538915

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Precision Trials LLC
Phoenix, Arizona, United States, 85032
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Colorado
1st Allergy and Clinical Resaerch center
Centennial, Colorado, United States, 80112
United States, Florida
Allergy Associates of the Palm Beaches
North Palm Beach, Florida, United States, 33408
United States, Georgia
Marietta Pulmonary Medicine
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical center
Chicago, Illinois, United States, 60612
United States, Indiana
South Bend Clinic LLP
South Bend, Indiana, United States, 46617
United States, Kentucky
Kentuky Lung Clinic, PSC
Hazard, Kentucky, United States, 41701
United States, Maryland
Institute For Allergy & Asthma
Wheaton, Maryland, United States, 20902
United States, Missouri
Cardinal Glennon Children's MC
Saint Louis, Missouri, United States, 63104
United States, New York
Women's and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
United States, Ohio
University Hospital Case medical center
Ciere, Ohio, United States, 44103
United States, Texas
AARA Research
Dallas, Texas, United States, 75231
Allergy/Immunology Research Center of north Texas
Dallas, Texas, United States, 75230
Allergy, Asthma & Immunology Clinic, PA
Irving, Texas, United States, 75063
United States, Washington
Bellingham Asthma, Allergy Clinic
Bellingham, Washington, United States, 98225
Sponsors and Collaborators
Biotest Pharmaceuticals Corporation
Investigators
Study Director: Shailesh Chavan, M.D. Biotest Pharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00538915     History of Changes
Other Study ID Numbers: Nabi-7101
Study First Received: October 1, 2007
Results First Received: January 4, 2012
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Biotest Pharmaceuticals Corporation:
immunodeficiency
humoral immunity
antibody deficiency
PID
PIDD

Additional relevant MeSH terms:
Disease
Immunologic Deficiency Syndromes
Pathologic Processes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014