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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.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thrombosis
Intervention Drug: Desirudin
Enrollment 516
Recruitment Details Patients were recruited between April 5, 2010 and February 18, 2011. Patients were recruited from inpatient medical and surgical services as well as surgical clinics when presenting for pre-operative services.
Pre-assignment Details  
Arm/Group Title Desirudin
Hide Arm/Group Description desirudin 15 mg twice daily for a minimum of 5 days
Period Title: Overall Study
Started 516
Completed 516
Not Completed 0
Arm/Group Title Desirudin
Hide Arm/Group Description desirudin 15 mg twice daily for a minimum of 5 days
Overall Number of Baseline Participants 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants
<=18 years
0
   0.0%
Between 18 and 65 years
387
  75.0%
>=65 years
129
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 516 participants
59  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants
Female
314
  60.9%
Male
202
  39.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 516 participants
516
1.Primary Outcome
Title Major Bleeding
Hide Description 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.
Time Frame 24 hours after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients receiving at least one dose of study drug
Arm/Group Title Desirudin
Hide Arm/Group Description:
desirudin 15 mg twice daily for a minimum of 5 days
Overall Number of Participants Analyzed 516
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Thrombosis
Hide Description
  • 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.
Time Frame Up until 24 hours after last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received at least one dose of study drug
Arm/Group Title Desirudin
Hide Arm/Group Description:
desirudin 15 mg twice daily for a minimum of 5 days
Overall Number of Participants Analyzed 516
Measure Type: Number
Unit of Measure: participants
8
Time Frame up to 30 days after cessation of study drug
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Desirudin
Hide Arm/Group Description desirudin 15 mg twice daily for a minimum of 5 days
All-Cause Mortality
Desirudin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Desirudin
Affected / at Risk (%) # Events
Total   80/516 (15.50%)    
Blood and lymphatic system disorders   
anemia  1  2/516 (0.39%)  2
leukopenia  1  1/516 (0.19%)  1
Cardiac disorders   
acute myocardial infarction  1  4/516 (0.78%)  4
atrial fibrillation  1  5/516 (0.97%)  5
cardiac failure congestive  1  2/516 (0.39%)  2
cardiogenic shock  1  1/516 (0.19%)  1
coronary artery disease  1  1/516 (0.19%)  1
Gastrointestinal disorders   
abdominal distension  1  1/516 (0.19%)  1
abdominal pain  1  2/516 (0.39%)  2
colonic obstruction  1  1/516 (0.19%)  1
constipation  1  3/516 (0.58%)  3
gastric hemorrhage  1  4/516 (0.78%)  4
gastrointestinal necrosis  1  1/516 (0.19%)  1
hematemesis  1  1/516 (0.19%)  1
ileus  1  1/516 (0.19%)  1
nausea  1  2/516 (0.39%)  2
pancreatic pseudocyst  1  1/516 (0.19%)  1
rectal hemorrhage  1  1/516 (0.19%)  1
small intestinal obstruction  1  7/516 (1.36%)  7
vomiting  1  1/516 (0.19%)  1
General disorders   
asthenia  1  1/516 (0.19%)  1
multi-organ failure  1  2/516 (0.39%)  2
Hepatobiliary disorders   
cholecystitis acute  1  1/516 (0.19%)  1
Infections and infestations   
abdominal abscess  1  1/516 (0.19%)  1
abdominal sepsis  1  1/516 (0.19%)  1
bacterial infection  1  1/516 (0.19%)  1
cellulitis  1  1/516 (0.19%)  1
clostridium difficile colitis  1  2/516 (0.39%)  2
diverticulitis  1  1/516 (0.19%)  1
osteomyelitis  1  1/516 (0.19%)  1
pelvic abscess  1  1/516 (0.19%)  1
peridiverticular abscess  1  1/516 (0.19%)  1
pneumonia  1  2/516 (0.39%)  2
post-procedural infection  1  1/516 (0.19%)  1
sepsis  1  3/516 (0.58%)  3
septic shock  1  1/516 (0.19%)  1
wound infection  1  1/516 (0.19%)  1
Injury, poisoning and procedural complications   
gatrointestinal disorder postoperative  1  1/516 (0.19%)  1
gastrointestinal stoma complication  1  1/516 (0.19%)  1
graft thrombosis  1  1/516 (0.19%)  1
postoperative ileus  1  5/516 (0.97%)  5
procedural nausea  1  1/516 (0.19%)  1
procedural pain  1  1/516 (0.19%)  1
procedural site reaction  1  1/516 (0.19%)  1
procedural vomiting  1  1/516 (0.19%)  1
splenic hematoma  1  1/516 (0.19%)  1
subdural hematoma  1  1/516 (0.19%)  1
Investigations   
white blood cell count increased  1  1/516 (0.19%)  1
Metabolism and nutrition disorders   
dehydration  1  1/516 (0.19%)  1
failure to thrive  1  1/516 (0.19%)  1
Musculoskeletal and connective tissue disorders   
pain in extremity  1  1/516 (0.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
bladder cancer  1  1/516 (0.19%)  1
lung neoplasm malignant  1  1/516 (0.19%)  1
plasmacytoma  1  1/516 (0.19%)  1
Nervous system disorders   
embolic stroke  1  1/516 (0.19%)  1
syncope  1  3/516 (0.58%)  3
Renal and urinary disorders   
hydronephrosis  1  1/516 (0.19%)  1
renal failure  1  3/516 (0.58%)  3
renal failure acute  1  5/516 (0.97%)  5
uretic obstruction  1  1/516 (0.19%)  1
Reproductive system and breast disorders   
pelvic fluid collection  1  1/516 (0.19%)  1
pelvic pain  1  1/516 (0.19%)  1
vaginal hemorrhage  1  1/516 (0.19%)  1
Respiratory, thoracic and mediastinal disorders   
atelectasis  1  1/516 (0.19%)  1
bronchial secretion retention  1  1/516 (0.19%)  1
chronic obstructive pulmonary disease  1  1/516 (0.19%)  1
diaphragmatic hernia  1  1/516 (0.19%)  1
dyspnea  1  1/516 (0.19%)  1
hypoxia  1  1/516 (0.19%)  1
pleural effusion  1  4/516 (0.78%)  4
pneumonia aspiration  1  1/516 (0.19%)  1
pulmonary embolism  1  1/516 (0.19%)  1
pulmonary oedema  1  1/516 (0.19%)  1
respiratory failure  1  4/516 (0.78%)  4
Surgical and medical procedures   
cholecystectomy  1  1/516 (0.19%)  1
Vascular disorders   
deep vein thrombosis  1  3/516 (0.58%)  3
haematoma  1  1/516 (0.19%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Desirudin
Affected / at Risk (%) # Events
Total   382/516 (74.03%)    
Blood and lymphatic system disorders   
anemia  1  45/516 (8.72%)  45
Cardiac disorders   
tachycardia  1  37/516 (7.17%)  37
hypotension  1  27/516 (5.23%)  27
Gastrointestinal disorders   
constipation  1  76/516 (14.73%)  76
nausea  1  76/516 (14.73%)  76
vomiting  1  31/516 (6.01%)  31
General disorders   
pyrexia  1  39/516 (7.56%)  39
asthenia  1  36/516 (6.98%)  36
generalised oedema  1  26/516 (5.04%)  26
Injury, poisoning and procedural complications   
procedural pain  1  59/516 (11.43%)  59
anemia postoperative  1  33/516 (6.40%)  33
Metabolism and nutrition disorders   
hypophosphataemia  1  38/516 (7.36%)  38
hyperglycemia  1  30/516 (5.81%)  30
hypokalemia  1  27/516 (5.23%)  27
hypocalcemia  1  26/516 (5.04%)  26
Respiratory, thoracic and mediastinal disorders   
breath sounds abnormal  1  41/516 (7.95%)  41
oxygen saturation decrease  1  32/516 (6.20%)  32
Vascular disorders   
oedema peripheral  1  31/516 (6.01%)  31
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
This was a multi-center, single-arm, observational safety trial. The lack of an active comparator does not allow us to make conclusions about the relative safety and efficacy of the product.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Trials
Organization: Canyon Pharmaceuticals
Phone: 888-434-7003
EMail: info@canyonpharma.com
Layout table for additonal information
Responsible Party: Canyon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00913133    
Other Study ID Numbers: DES-09-02
First Submitted: May 26, 2009
First Posted: June 4, 2009
Results First Submitted: November 30, 2012
Results First Posted: January 3, 2013
Last Update Posted: January 10, 2013