Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Primary Purpose
Primary Immune Deficiency Disorders (PIDD)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immune Deficiency Disorders (PIDD) focused on measuring immunodeficiency, humoral immunity, antibody deficiency, PID, PIDD
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.
Sites / Locations
- University of Alabama
- Precision Trials LLC
- Children's Hospital of Los Angeles
- 1st Allergy and Clinical Resaerch center
- Allergy Associates of the Palm Beaches
- Marietta Pulmonary Medicine
- Rush University Medical center
- South Bend Clinic LLP
- Kentuky Lung Clinic, PSC
- Institute For Allergy & Asthma
- Cardinal Glennon Children's MC
- Women's and Children's Hospital of Buffalo
- University Hospital Case medical center
- Allergy/Immunology Research Center of north Texas
- AARA Research
- Allergy, Asthma & Immunology Clinic, PA
- Bellingham Asthma, Allergy Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nabi-IGIV Infused Every 3- or 4-Weeks
Arm Description
Outcomes
Primary Outcome Measures
Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00538915
Brief Title
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
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADMA Biologics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency Disorders (PIDD)
Keywords
immunodeficiency, humoral immunity, antibody deficiency, PID, PIDD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nabi-IGIV Infused Every 3- or 4-Weeks
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Serious Bacterial Infections (SBIs) Per Person-year on Treatment
Description
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shailesh Chavan, M.D.
Organizational Affiliation
Biotest Pharmaceuticals Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Precision Trials LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
1st Allergy and Clinical Resaerch center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Allergy Associates of the Palm Beaches
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Marietta Pulmonary Medicine
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rush University Medical center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
South Bend Clinic LLP
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Kentuky Lung Clinic, PSC
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Institute For Allergy & Asthma
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Cardinal Glennon Children's MC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Women's and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
University Hospital Case medical center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States
Facility Name
Allergy/Immunology Research Center of north Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
AARA Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Allergy, Asthma & Immunology Clinic, PA
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Bellingham Asthma, Allergy Clinic
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
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