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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)

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ClinicalTrials.gov Identifier: NCT00538915
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : March 26, 2012
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Biotest Pharmaceuticals Corporation

Tracking Information
First Submitted Date  ICMJE October 1, 2007
First Posted Date  ICMJE October 3, 2007
Results First Submitted Date  ICMJE January 4, 2012
Results First Posted Date  ICMJE March 26, 2012
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE September 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
Serious Bacterial Infections (SBIs) Compared to Historical Control Data. [ Time Frame: One year ]
Serious bacterial infections (SBIs) rate per person-years, including bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia and visceral abscess.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2007)
Primary efficacy parameter: a rate of serious bacterial infections meeting FDA criteria (defined as bacteremia/sepsis, bacterial meningitis, osteomyelitis/septic arthritis, bacterial pneumonia, and visceral abscess) per person-year on treatment <1.0. [ Time Frame: One year ]
Change History Complete list of historical versions of study NCT00538915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2007)
  • A key safety parameter is the proportion of infusions with one or more infusion-related adverse events (i.e. temporally associated with an infusion within 72 hours of infusion). [ Time Frame: One year ]
  • The primary PK parameters will include maximum IgG serum concentration (Cmax) and the area under the IgG concentration-time curve (AUC(0-tau)) in which tau is the end of the dosing interval. [ Time Frame: After 4th or 5th infusion of IGIV ]
  • Descriptive analyses of PK parameters for specific antibodies (anti-pneumococcal polysaccharide antibody, anti-Haemophilus influenzae B antibody, and anti-tetanus antibody) will be performed [ Time Frame: After 4th or 5th infusion of IGIV ]
  • Time (days) to first serious bacterial infection. [ Time Frame: Up to 1 year ]
  • Days missed of school/work due to infections. [ Time Frame: One year ]
  • All infections of any kind/seriousness during the study. [ Time Frame: One year. ]
  • Number of hospitalizations due to infection. [ Time Frame: One year ]
  • Days on antibiotics. [ Time Frame: One year ]
  • All adverse events regardless of causality assessment by the investigator. [ Time Frame: One year ]
  • Markers of blood-borne infections before, during, and for 3 months after the last study drug infusion (HBsAg, anti-HCV antibody and HCV NAT, anti-HIV 1/2, and Parvovirus B19 NAT. [ Time Frame: Baseline, before infusions 8 and 12, and 3 months after last infusion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Immune Deficiency Disorders (PIDD)
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Nabi-IGIV Infused Every 3- or 4-Weeks
Intervention: Biological: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2012)
63
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2007)
60
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00538915
Other Study ID Numbers  ICMJE Nabi-7101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biotest Pharmaceuticals Corporation
Study Sponsor  ICMJE Biotest Pharmaceuticals Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Shailesh Chavan, M.D. Biotest Pharmaceuticals Corporation
PRS Account Biotest Pharmaceuticals Corporation
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP