A Safety Study of Eptifibatide in Patients With Sickle Cell Disease

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 platelet activation and the resultant inflammatory responses are important contributors to the problems of sickle cell disease. Sickle cell disease has been referred to both as a condition associated with increased risk of blood clots and increased inflammation. A painful crisis represents the most common cli nical problem in sickle cell disease, but the treatment of these crises remains inadequate.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Eptifibatide

Criteria

Inclusion Criteria:

1. Age between 18 and 55 years

2. Have confirmed diagnosis of sickle cell anemia or sickle beta zero thalassemia

3. Have a serum creatinine

4. Have serum transaminase values < 3 times upper limits of normal

5. Have a platelet count >/= 150 x 10^9/L

6. Have normal baseline coagulation profile

7. Sudden onset of pain involving one or more sites and typical of usual pain episodes

8. Have adequate intravenous access

9. Be able to understand the requirements of the study and be willing to give informed consent

10. 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 Criteria:

1. Have a baseline hemoglobin < 6.0 gm/dl

2. Have a history of major gastrointestinal bleeding or a bleeding diathesis

3. Have an ongoing episode of acute chest syndrome

4. Have a past history of clinically overt stroke(s)

5. Have severe hypertension (systolic blood pressure > 200mmHg and/or diastolic BP >110mmHg) not adequately controlled on hypertensive medication

6. Have had major surgery within the six weeks preceding enrollment

7. Are pregnant or breastfeeding

8. Are on chronic anticoagulation or antiplatelet (including non-steroidal anti-inflammatory drugs) therapy

9. Have a history of metastatic cancer

10. Are on a chronic transfusion program or have received a blood transfusion in the prior 8 weeks

11. Have a positive urine toxicology screen for phencyclidine, cocaine or amphetamines.

12. Have a history of alcohol abuse

13. Have received any investigational drugs within the past 4 weeks.