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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)

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
Results First Received: January 4, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Immune Deficiency Disorders (PIDD)
Intervention: Biological: Nabi-IGIV 10% [Immune Globulin Intravenous (Human). 10%]

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled: 24 September 2007. Last subject completed: 24 July 2009. 15 investigative sites, hospital clinics and private physician clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was an open study. All enrolled subjects received study medication.

Reporting Groups
  Description
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval 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.

Participant Flow:   Overall Study
    Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval  
STARTED     63  
COMPLETED     52  
NOT COMPLETED     11  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval 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.

Baseline Measures
    Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval  
Number of Participants  
[units: participants]
  63  
Age  
[units: participants]
 
<=18 years     12  
Between 18 and 65 years     42  
>=65 years     9  
Gender  
[units: participants]
 
Female     32  
Male     31  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard L. Wasserman, M.D., Ph.D.
Organization: DallasAllergyImmunology
phone: (972) 566-7788
e-mail: drrichwasserman@gmail.com


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