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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426270
First Posted: January 24, 2007
Last Update Posted: August 1, 2014
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):
Octapharma
Results First Submitted: April 7, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[Units: Participants]
 116 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (19.1) 
Gender 
[Units: Participants]
 
Female   74 
Male   42 


  Outcome Measures
  Show All Outcome Measures

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00426270     History of Changes
Other Study ID Numbers: GAM10-02
First Submitted: January 22, 2007
First Posted: January 24, 2007
Results First Submitted: April 7, 2014
Results First Posted: May 8, 2014
Last Update Posted: August 1, 2014