Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis (DESIR-ABLE)
This study has been completed.
Sponsor:
Canyon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00913133
First received: May 26, 2009
Last updated: January 6, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thrombosis |
Drug: Desirudin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE) |
Resource links provided by NLM:
Further study details as provided by Canyon Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Major Bleeding [ Time Frame: 24 hours after last dose of study drug ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Thrombosis [ Time Frame: Up until 24 hours after last dose of study drug ] [ Designated as safety issue: Yes ]
- 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.
| Enrollment: | 516 |
| Study Start Date: | March 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Desirudin
desirudin 15 mg twice daily for a minimum of 5 days
|
Drug: Desirudin
Desirudin SC 15mg q12h
Other Name: Iprivask
|
Detailed Description:
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Provide written informed consent before initiation of any study related procedures.
- Be at least 18 years of age.
- Patients requiring anticoagulation for the prophylaxis of thrombosis.
- In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.
Exclusion Criteria:
- Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
- Intracranial neoplasm, arteriovenous malformation or aneurysm.
- 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.
- Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
- 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).
- Refusal to undergo blood transfusion should it become necessary
- Active bleeding or irreversible coagulation abnormality.
- Uncontrolled hypertension defined as a blood pressure > or equal to 180/110 mmHg.
- Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913133
Locations
| United States, Colorado | |
| University of Colorado Health Science Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| University of South Florida, Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Saint Joseph's Research Institute | |
| Atlanta, Georgia, United States, 30342 | |
| Southeastern Center for Clinical Trials | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Provena St. Joseph's Medical Center | |
| Joliet, Illinois, United States, 60435 | |
| Illinois Lung and Critical Care Institute | |
| Peoria, Illinois, United States, 61606 | |
| United States, Missouri | |
| St. John's Mercy Medical Center | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Jersey | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10065 | |
| Stony Brook University Medical Center | |
| Stony Brook, New York, United States, 11794-8191 | |
| United States, North Carolina | |
| Forsyth Regional Medical Center | |
| Winston-Salem, North Carolina, United States, 55902 | |
| Forsyth Regional Medical Center | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| The Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| Drexel University College of Medicine | |
| Philadelphia, Pennsylvania, United States, 19102-1192 | |
| United States, Texas | |
| Research Concepts, Memorial Hermann Healthcare System | |
| Houston, Texas, United States, 77024 | |
| United States, Virginia | |
| Carilion Roanoke Memorial Hospital | |
| Roanoke, Virginia, United States, 24014 | |
Sponsors and Collaborators
Canyon Pharmaceuticals, Inc.
Investigators
| Study Director: | Dawn Bell, PharmD | Canyon Pharmaceuticals, Inc. |
| Principal Investigator: | Jerrold Levy, MD, FAHA | Emory University |
More Information
No publications provided
| Responsible Party: | Canyon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00913133 History of Changes |
| Other Study ID Numbers: | DES-09-02 |
| Study First Received: | May 26, 2009 |
| Results First Received: | November 30, 2012 |
| Last Updated: | January 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Canyon Pharmaceuticals, Inc.:
|
Anticoagulation Prophylaxis Desirudin Direct thrombin inhibitor Heparin-induced thrombocytopenia |
Additional relevant MeSH terms:
|
Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Antithrombins Desirudin Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anticoagulants Hematologic Agents Therapeutic Uses Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013