Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00426270
First received: January 22, 2007
Last updated: July 28, 2014
Last verified: July 2014
Results First Received: April 7, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Immune Thrombocytopenic Purpura
Intervention: Drug: Octagam 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was incorrectly enrolled in the study and was not included in the efficacy analyses but was included in the safety population.

Reporting Groups
  Description
Octagam 10% 1 g/kg/Day Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

Participant Flow:   Overall Study
    Octagam 10% 1 g/kg/Day  
STARTED     116  
COMPLETED     110  
NOT COMPLETED     6  
Incorrectly Enrolled in the Study                 1  
Adverse Event                 5  



  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.
Safety population: All participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Octagam 10% 1 g/kg/Day Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

Baseline Measures
    Octagam 10% 1 g/kg/Day  
Number of Participants  
[units: participants]
  116  
Age  
[units: Years]
Mean ± Standard Deviation
  47.7  ± 19.1  
Gender  
[units: Participants]
 
Female     74  
Male     42  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Clinical Response   [ Time Frame: Day 2 to Day 7 ]

2.  Secondary:   Time to Achieve a Clinical Response   [ Time Frame: Day 2 to Day 7 ]

3.  Secondary:   Maximum Platelet Count   [ Time Frame: Day 2 to the end of the study (Day 63) ]

4.  Secondary:   Duration of the Clinical Response   [ Time Frame: Day 2 to the end of the study (Day 63) ]

5.  Secondary:   Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7   [ Time Frame: Day 7 ]


  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 NOT 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:  
Name/Title: Michael Eppolito
Organization: Octapharma USA
phone: 201 604-1155
e-mail: michael.eppolito@octapharma.com


No publications provided by Octapharma

Publications automatically indexed to this study:

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00426270     History of Changes
Other Study ID Numbers: GAM10-02
Study First Received: January 22, 2007
Results First Received: April 7, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut
Czech Republic: State Institute for Drug Control
Austria: Agency for Health and Food Safety
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)