P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00603642
First received: January 17, 2008
Last updated: February 4, 2011
Last verified: February 2011
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Idiopathic Thrombocytopenic Purpura
Interventions: Drug: Placebo
Drug: AMG 531

  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
Participants were enrolled from 20 November 2007 through 11 December 2008

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
Placebo Placebo administered subcutaneously once weekly for 12 weeks
Romiplostim Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg

Participant Flow:   Overall Study
    Placebo     Romiplostim  
STARTED     12     22  
COMPLETED     12     22  
NOT COMPLETED     0     0  



  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.
No text entered.

Reporting Groups
  Description
Placebo Placebo administered subcutaneously once weekly for 12 weeks
Romiplostim Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
Total Total of all reporting groups

Baseline Measures
    Placebo     Romiplostim     Total  
Number of Participants  
[units: participants]
  12     22     34  
Age  
[units: Years]
Mean ± Standard Deviation
  47.6  ± 13.4     58.5  ± 12.6     54.7  ± 13.7  
Gender  
[units: Participants]
     
Female     10     14     24  
Male     2     8     10  
Race/Ethnicity, Customized  
[units: Participants]
     
Japanese     12     22     34  
Other     0     0     0  
Platelet Count  
[units: 10^9/L]
Mean ± Standard Deviation
  15.8  ± 8.6     18.4  ± 8.3     17.5  ± 8.4  



  Outcome Measures
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1.  Primary:   Weeks With Weekly Platelet Response   [ Time Frame: 12 weeks (Weeks 2 - 13) ]

2.  Secondary:   Increased Platelet Count From Baseline of at Least 20 x 10^9/L   [ Time Frame: Baseline, 12 weeks (Weeks 2 - 13) ]

3.  Secondary:   Change From Baseline in Mean of Last 4 Weekly Platelet Counts   [ Time Frame: 12 weeks (Weeks 2 - 13) ]

4.  Secondary:   Weeks With Platelet Count Between 50 and 200   [ Time Frame: 12 weeks (Weeks 2 - 13) ]

5.  Secondary:   Rescue Medication(s)   [ Time Frame: 12 weeks (Weeks 2 - 13) ]


  Serious Adverse Events


  Other Adverse Events


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


No publications provided


Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00603642     History of Changes
Other Study ID Numbers: 20060216
Study First Received: January 17, 2008
Results First Received: November 18, 2010
Last Updated: February 4, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare