Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00322556
First received: May 5, 2006
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: September 27, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Agammaglobulinemia
IgG Deficiency
Common Variable Immunodeficiency
Intervention: Drug: Immunoglobulins Intravenous (Human)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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. ]
  Show Outcome Measure 1

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

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

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

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

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. ]
  Show Outcome Measure 6

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

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

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. ]
  Show Outcome Measure 9


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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
No text entered.  


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
Study First Received: May 5, 2006
Results First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration