A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00787332
First received: November 6, 2008
Last updated: January 6, 2013
Last verified: January 2013
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Suspected Heparin-Induced Thrombocytopenia
Intervention: Drug: Desirudin or Argatroban®

  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
Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they had severe renal failure (CrCL<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.

Reporting Groups
  Description
Desirudin Patients with suspected HIT randomized to SC Desirudin in a 1:1 ratio
Argatroban® Patients with suspected HIT randomized to IV Argatroban® in a 1:1 ratio

Participant Flow:   Overall Study
    Desirudin     Argatroban®  
STARTED     8     8  
COMPLETED     8     8  
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
Desirudin Patients with suspected HIT randomized to SC Desirudin i
Argatroban® Patients with suspected HIT randomized to IV Argatroban®
Total Total of all reporting groups

Baseline Measures
    Desirudin     Argatroban®     Total  
Number of Participants  
[units: participants]
  8     8     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     6     12  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  69  ± 9.5     62  ± 9.3     65  ± 9  
Gender  
[units: participants]
     
Female     3     3     6  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     8     8     16  



  Outcome Measures

1.  Primary:   New Thrombosis, Amputation, Death, Major and Minor Bleeding   [ Time Frame: 30 days ]


  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
Study stopped early due to poor enrollment.


  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: Director of Clinical Trials
Organization: Canyon Pharmaceuticals
phone: 888-434-7003
e-mail: info@canyonpharma.com


No publications provided by Canyon Pharmaceuticals, Inc.

Publications automatically indexed to this study:

Responsible Party: Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00787332     History of Changes
Other Study ID Numbers: DES-08-01
Study First Received: November 6, 2008
Results First Received: November 29, 2012
Last Updated: January 6, 2013
Health Authority: United States: Food and Drug Administration