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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Immune Deficiency Disorders (PIDD)
Intervention Biological: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]
Enrollment 63
Recruitment Details First subject enrolled: 24 September 2007. Last subject completed: 24 July 2009. 15 investigative sites, hospital clinics and private physician clinics.
Pre-assignment Details This was an open study. All enrolled subjects received study medication.
Arm/Group Title Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Hide Arm/Group Description Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
Period Title: Overall Study
Started 63
Completed 52
Not Completed 11
Arm/Group Title Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Hide Arm/Group Description Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
Overall Number of Baseline Participants 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
<=18 years
12
  19.0%
Between 18 and 65 years
42
  66.7%
>=65 years
9
  14.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants
Female
32
  50.8%
Male
31
  49.2%
1.Primary Outcome
Title Serious Bacterial Infections (SBIs) Compared to Historical Control Data.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
63 subjects enrolled, received treatment and included in the Safety population. 5 subjects excluded from the Intent To Treat (ITT) population due to significant, excessive protocol violations and an insufficient number of infusions to elicit the intended effect.
Arm/Group Title Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Hide Arm/Group Description:
Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: SBIs Per Total Person-Years
0.035
Time Frame An event was only included in the analysis of Adverse Events (AEs) if it had an onset date between the first administration of study drug and 28 days after the last administration of study drug, inclusive.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Hide Arm/Group Description Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
All-Cause Mortality
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Affected / at Risk (%) # Events
Total   7/63 (11.11%)    
Gastrointestinal disorders   
Colitis  1  1/63 (1.59%)  1
Intestinal Obstruction  1  1/63 (1.59%)  1
Vomiting  1  1/63 (1.59%)  1
Infections and infestations   
Appendicitis  1  1/63 (1.59%)  1
Obstructive Chronic Bronchitis With Acute Exacerbation  1  1/63 (1.59%)  1
Pneumonia Bacterial  1  1/63 (1.59%)  1
Injury, poisoning and procedural complications   
Hip Fracture  1  1/63 (1.59%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/63 (1.59%)  1
Psychiatric disorders   
Mental Status Changes  1  1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  1  1/63 (1.59%)  1
Vascular disorders   
Hypotension  1  1/63 (1.59%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval
Affected / at Risk (%) # Events
Total   47/63 (74.60%)    
Gastrointestinal disorders   
Diarrhea  1  4/63 (6.35%)  4
Nausea  1  5/63 (7.94%)  10
General disorders   
Fatigue  1  15/63 (23.81%)  62
Infusion Site Reaction  1  5/63 (7.94%)  6
Infections and infestations   
Sinusitis  1  5/63 (7.94%)  5
Investigations   
Blood Pressure Increased  1  4/63 (6.35%)  5
Nervous system disorders   
Dizziness  1  4/63 (6.35%)  4
Headache  1  27/63 (42.86%)  147
Lethargy  1  4/63 (6.35%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard L. Wasserman, M.D., Ph.D.
Organization: DallasAllergyImmunology
Phone: (972) 566-7788
EMail: drrichwasserman@gmail.com
Layout table for additonal information
Responsible Party: Biotest Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00538915     History of Changes
Other Study ID Numbers: Nabi-7101
First Submitted: October 1, 2007
First Posted: October 3, 2007
Results First Submitted: January 4, 2012
Results First Posted: March 26, 2012
Last Update Posted: March 10, 2017