Status:
TERMINATED
A Safety Study of Eptifibatide in Patients With Sickle Cell Disease
Lead Sponsor:
University of North Carolina, Chapel Hill
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the safety of eptifibatide in sickle cell patients and how well it works during the course of painful crises. The overall hypothesis that we seek to test is that increased pla...
Detailed Description
Sickle cell disease has been referred to both as a condition associated with increased risk of blood clots and increased inflammation. Despite the abundant laboratory evidence of abnormal blood clotti...
Eligibility Criteria
Inclusion
- Age between 18 and 55 years
- Have confirmed diagnosis of sickle cell anemia or sickle beta zero thalassemia
- Have a serum creatinine \</= 1.2 mg/dl
- Have serum transaminase values \< 3 times upper limits of normal
- Have a platelet count \>/= 150 x 10\^9/L
- Have normal baseline coagulation profile
- Sudden onset of pain involving one or more sites and typical of usual pain episodes
- Have adequate intravenous access
- Be able to understand the requirements of the study and be willing to give informed consent
- Women of child-bearing age must be practicing (and will continue to practice for the course of the study) an adequate method of contraception (oral contraception, depo-provera, bilateral tubal ligation or barrier method)
Exclusion
- Have a baseline hemoglobin \< 6.0 gm/dl
- Have a history of major gastrointestinal bleeding or a bleeding diathesis
- Have an ongoing episode of acute chest syndrome
- Have a past history of clinically overt stroke(s)
- Have severe hypertension (systolic blood pressure \> 200mmHg and/or diastolic BP \>110mmHg) not adequately controlled on hypertensive medication
- Have had major surgery within the six weeks preceding enrollment
- Are pregnant or breastfeeding
- Are on chronic anticoagulation or antiplatelet (including non-steroidal anti-inflammatory drugs) therapy
- Have a history of metastatic cancer
- Are on a chronic transfusion program or have received a blood transfusion in the prior 8 weeks
- Have a positive urine toxicology screen for phencyclidine, cocaine or amphetamines.
- Have a history of alcohol abuse
- Have received any investigational drugs within the past 4 weeks.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00834899
Start Date
January 1 2009
End Date
March 1 2012
Last Update
June 27 2013
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7305