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Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322556
First Posted: May 8, 2006
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CSL Behring
Results First Submitted: September 27, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Intervention: Drug: Immunoglobulins Intravenous (Human)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
IgPro10 A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.

Participant Flow:   Overall Study
    IgPro10
STARTED   55 
COMPLETED   43 
NOT COMPLETED   12 
Adverse Event                1 
Withdrawal by Subject                1 
Lost to Follow-up                3 
Other Reason                7 



  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.
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Reporting Groups
  Description
IgPro10 A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.

Baseline Measures
   IgPro10 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age 
[Units: Years]
Mean (Standard Deviation)
 30  (21) 
Age, Customized 
[Units: Participants]
 
3 to < 12 years   13 
12 to < 16 years   8 
16 to < 65 years   30 
>= 65 years   4 
Gender 
[Units: Participants]
 
Female   29 
Male   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Infusions With One or More Temporally-associated Adverse Events (AEs).   [ Time Frame: During each infusion, and within 48 or 72 hours after the end of each infusion. ]

2.  Primary:   Influence of Infusion Rate on Temporally-Associated AEs   [ Time Frame: Within 72 hours after each infusion ]

3.  Primary:   Rate of AEs by Severity and Relationship   [ Time Frame: For the duration of the study, up to approximately 29 months ]

4.  Primary:   Number of Subjects With Clinically Significant Changes in Vital Signs.   [ Time Frame: Before, during, and after each infusion. ]

5.  Secondary:   Annualized Rate of Acute Serious Bacterial Infections.   [ Time Frame: For the duration of the study, up to approximately 29 months ]

6.  Secondary:   Number of Days Out of Work / School / Kindergarten / Day Care or Inability to Perform Normal Activities Due to Illness.   [ Time Frame: For the duration of the study, up to approximately 29 months. ]

7.  Secondary:   Number of Days of Hospitalization.   [ Time Frame: For the duration of the study, up to approximately 29 months ]

8.  Secondary:   Annualized Rate of Any Infection.   [ Time Frame: For the duration of the study, up to approximately 29 months. ]

9.  Secondary:   Trough Levels of Total Immunoglobulin (IgG) Serum Concentrations.   [ Time Frame: Prior to each infusion; every 3 or 4 weeks depending upon the dosing schedule. ]


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com


Publications of Results:

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00322556     History of Changes
Other Study ID Numbers: ZLB05_006CR
First Submitted: May 5, 2006
First Posted: May 8, 2006
Results First Submitted: September 27, 2012
Results First Posted: October 26, 2012
Last Update Posted: October 26, 2012