ThrombosisPhase 4DESIR-ABLENCT00913133
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
A Phase 4 study testing Desirudin in people with Thrombosis, run by Canyon Pharmaceuticals, Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Desirudin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2010to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Saint Joseph's Research Institute
Atlanta, Georgia, 30342
University of Colorado Health Science Center
Aurora, Colorado, 80045
The Ohio State University Medical Center
Columbus, Ohio, 43210
Southeastern Center for Clinical Trials
Decatur, Georgia, 30033
Research Concepts, Memorial Hermann Healthcare System
Houston, Texas, 77024
Provena St. Joseph's Medical Center
Joliet, Illinois, 60435
Weill Cornell Medical College
New York, New York, 10065
Illinois Lung and Critical Care Institute
Peoria, Illinois, 61606
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102-1192
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Stony Brook University Medical Center
Stony Brook, New York, 11794-8191
Overlook Hospital
Summit, New Jersey, 07901
University of South Florida, Tampa General Hospital
Tampa, Florida, 33606
Forsyth Regional Medical Center
Winston-Salem, North Carolina, 27103
Forsyth Regional Medical Center
Winston-Salem, North Carolina, 55902
About this study
Official title: Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
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.
Read the detailed description
Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.
- Conditions
- Thrombosis
- Being tested
- Desirudin
- Keywords
- Anticoagulation, Prophylaxis, Desirudin, Direct thrombin inhibitor, Heparin-induced thrombocytopenia
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesirudinDrug
Also called Iprivask
Desirudin SC 15mg q12h
| Study group | Role | What they receive |
|---|---|---|
| Desirudin | Experimental | desirudin 15 mg twice daily for a minimum of 5 days Receives: Drug: Desirudin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Bleeding
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.
Measured: 24 hours after last dose of study drug
Secondary outcomes (1)
Thrombosis
- 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.
Measured: Up until 24 hours after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canyon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dawn Bell, PharmD, Study director, Canyon Pharmaceuticals, Inc.Jerrold Levy, MD, FAHA, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913133
- Sponsor's protocol ID
- DES-09-02
- Acronym
- DESIR-ABLE
- Status last verified
- Jan 2013
- First submitted
- 26 May 2009
- Last updated
- 10 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial of Desirudin for the Prophylaxis of Thrombosis: an Alternative to Heparin-Based Anticoagulation (DESIR-ABLE)
- ClinicalTrials.gov ID
- NCT00913133
- Acronym / sponsor ID
- DESIR-ABLE / DES-09-02
- Conditions
- Thrombosis
- Keywords
- Anticoagulation, Prophylaxis, Desirudin, Direct thrombin inhibitor, Heparin-induced thrombocytopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Canyon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Posted 3 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Desirudin | Experimental | Drug: Desirudindesirudin 15 mg twice daily for a minimum of 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesirudinAlso: IprivaskDesirudin SC 15mg q12h | Drug | Desirudin |
Primary outcome
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.
1 secondary outcome
Thrombosis
Time frame: Up until 24 hours after last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Bell, PharmD study director
Canyon Pharmaceuticals, Inc.
Jerrold Levy, MD, FAHA principal investigator
Emory University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desirudin in people with Thrombosis, run by Canyon Pharmaceuticals, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Bleeding (time frame: 24 hours after last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2013.