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Treatment of Chronic Immune Thrombocytopenic Purpura (ITP) With Intravenous Immunoglobulin IgPro10

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168038
First received: September 12, 2005
Last updated: October 18, 2011
Last verified: October 2011
History of Changes
Results First Received: August 22, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Immune Thrombocytopenic Purpura
Intervention: Biological: Immunoglobulin 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
The study was performed as a multicenter study at 17 centers, 6 in Poland, 4 in the Ukraine, 4 in Russia, 1 in Germany, 1 in Italy and 1 in the United Kingdom (UK).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One enrolled subject was withdrawn prior to receiving treatment due to a non-fatal adverse event. This subject was not included in the analyses.

Reporting Groups
  Description
IgPro10 All subjects treated with IgPro10

Participant Flow:   Overall Study
    IgPro10  
STARTED     57  
COMPLETED     55  
NOT COMPLETED     2  
Adverse Event                 1  
Therapy failure                 1  



  Baseline Characteristics
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Reporting Groups
  Description
IgPro10 All subjects treated with IgPro10

Baseline Measures
    IgPro10  
Number of Participants  
[units: participants]
 		  57  
Age  
[units: years]
Mean ± Standard Deviation 		  38  ± 15  
Gender  
[units: participants]
 		 
Female     34  
Male     23  
Race/Ethnicity, Customized  
[units: participants]
 		 
Caucasian     57  
Weight  
[units: kg]
Mean ± Standard Deviation 		  74.0  ± 15.5  
Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation 		  25.69  ± 4.56  



  Outcome Measures
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1.  Primary:   Platelet Response   [ Time Frame: 7 days ]
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2.  Secondary:   Regression of Hemorrhage (Skin)   [ Time Frame: up to 29 days ]
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3.  Secondary:   Regression of Hemorrhage (Oral Cavity)   [ Time Frame: 29 days ]
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4.  Secondary:   Regression of Hemorrhage (Genitourinary Tract)   [ Time Frame: 29 days ]
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5.  Secondary:   Regression of Hemorrhage (Nose)   [ Time Frame: 29 days ]
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6.  Secondary:   Regression of Hemorrhage (Internal)   [ Time Frame: 29 days ]
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7.  Secondary:   Time to Platelet Response   [ Time Frame: 29 days ]
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8.  Secondary:   Duration of Platelet Response   [ Time Frame: up to 29 days ]
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9.  Secondary:   Maximum Platelet Level   [ Time Frame: 29 days ]
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Measure Type Secondary
Measure Title Maximum Platelet Level
Measure Description Maximum absolute platelet count achieved over the duration of the study.
Time Frame 29 days  
Safety Issue No  

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.
ITT analysis. The ITT population comprised all subjects who received at least once study medication.

Reporting Groups
  Description
IgPro10 All subjects treated with IgPro10

Measured Values
    IgPro10  
Number of Participants Analyzed  
[units: participants]
 		  57  
Maximum Platelet Level  
[units: 10^9/L]
Median ( Full Range ) 		  154  
  ( 10 to 1049 )  

No statistical analysis provided for Maximum Platelet Level




  Serious Adverse Events
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  Other Adverse Events
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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.


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
e-mail: clinicaltrials@cslbehring.com


Publications of Results:


Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00168038     History of Changes
Other Study ID Numbers: ZLB03_003CR, 2004-000537-11
Study First Received: September 12, 2005
Results First Received: August 22, 2011
Last Updated: October 18, 2011
Health Authority: Germany: Paul-Ehrlich-Institut
Russia: Pharmacological Committee, Ministry of Health
Ukraine: Ministry of Health
United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Poland: Ministry of Health