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

• 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: Canyon Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Canyon Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: May 26, 2009
• First Posted Date: June 4, 2009
• Results First Submitted Date: November 30, 2012
• Results First Posted Date: January 3, 2013
• Last Update Posted Date: January 10, 2013
• Study Start Date: March 2010
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thrombosis

Intervention

Drug: Desirudin

Desirudin SC 15mg q12h

Other Name: Iprivask

Study Arms

Experimental: Desirudin

desirudin 15 mg twice daily for a minimum of 5 days

Intervention: Drug: Desirudin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 7, 2012): 516
• Original Estimated Enrollment (submitted: June 3, 2009): 500
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00913133
• Other Study ID Numbers: DES-09-02
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Canyon Pharmaceuticals, Inc.
• Study Sponsor: Canyon Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

• 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