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Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (DESIR-ABLE)

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.
 
ClinicalTrials.gov Identifier: NCT00913133
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : January 3, 2013
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE May 26, 2009
First Posted Date  ICMJE June 4, 2009
Results First Submitted Date  ICMJE November 30, 2012
Results First Posted Date  ICMJE January 3, 2013
Last Update Posted Date January 10, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2010)
Major Bleeding [ Time Frame: 24 hours after last dose of study drug ]
Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Evaluate the clinical utility and safety of Desirudin in patients with or without thrombosis who require an alternative to heparin-based anticoagulation. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2010)
Thrombosis [ Time Frame: Up until 24 hours after last dose of study drug ]
  • New onset symptomatic thrombosis requiring medical or surgical intervention;
  • Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
Official Title  ICMJE Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
Brief Summary The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
Detailed Description Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Thrombosis
Intervention  ICMJE Drug: Desirudin
Desirudin SC 15mg q12h
Other Name: Iprivask
Study Arms  ICMJE Experimental: Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
Intervention: Drug: Desirudin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
516
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
500
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent before initiation of any study related procedures.
  2. Be at least 18 years of age.
  3. Patients requiring anticoagulation for the prophylaxis of thrombosis.
  4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

Exclusion Criteria:

  1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
  2. Intracranial neoplasm, arteriovenous malformation or aneurysm.
  3. Severe renal insufficiency (chronic or acute) with a GFR of < or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
  4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
  5. Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
  6. Refusal to undergo blood transfusion should it become necessary
  7. Active bleeding or irreversible coagulation abnormality.
  8. Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
  9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
  10. Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913133
Other Study ID Numbers  ICMJE DES-09-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Canyon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Canyon Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dawn Bell, PharmD Canyon Pharmaceuticals, Inc.
Principal Investigator: Jerrold Levy, MD, FAHA Emory University
PRS Account Canyon Pharmaceuticals, Inc.
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP