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| Sponsored by: |
The University of North Carolina, Chapel Hill |
|---|---|
| Information provided by: | The University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00834899 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sickle Cell Disease |
Drug: Eptifibatide Drug: Placebo |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I/II Randomized, Double-Blink, Placebo-Controlled Study to Evalute the Safety of Eptifibatide as Treatment for Acute Pain Episodes in Sickle Cell Disease |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
As soon as eligible patients are identified and provide consent to participate in the study, patients randomized to the eptifibatide arm will receive two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
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Drug: Eptifibatide
Patients randomized to eptifibatide will receive two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
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2: Placebo Comparator
As soon as eligible patients are identified and provide consent to participate in the study, patients randomized to the placebo arm will receive a saline solution delivered at a volume and rate identical to that of the active drug.
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Drug: Placebo
Patients randomized to the placebo arm will receive a saline solution delivered at a volume and rate identical to that of the active drug.
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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 clotting and inflammation, the contribution of these changes to the problems experienced by patients with sickle cell disease remains uncertain. In additional to abnormal blood clotting, platelets (small blood cells that help blood clotting) are more activated in sickle cell disease patients compared to healthy patients without this disease.
In addition, when sickle cell disease patients experience a painful crisis, there is evidence that the platelet activation and abnormal blood clotting increase even further. Activated platelets release a substance called CD40 ligand, which can increase how sticky the lining of blood vessels are and can increase the abnormal blood clotting. The level of CD40 ligand is much higher in sickle cell disease patients compared to healthy individuals without this disease. In addition, the levels increase even further when sickle cell patients are experiencing a painful crisis.
Painful crisis represent the most common clinical problem in sickle cell disease, and are largely responsible for making the lives of these patients so unpredictable. However, the treatment of these painful crisis remains inadequate, consisting mainly of strong pain medications. In this study, we will evaluate the safety of eptifibatide in sickle cell patients and how well it works during the course of painful crises. At the completion of this trial, we will have an improved understanding of the contribution of platelet activation and inflammation to the problems in sickle cell disease.
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. We believe that by decreasing platelet stickiness, and the release of mediators of inflammation and abnormal blood clotting, eptifibatide will affect the clinical course of complications in this disease.
If the results from our study support the hypothesis that eptifibatide is safe and effective in this population, we plan on carrying out larger studies to more definitively evaluate the safety of eptifibatide and how well it works in the treatment and/or prevention of painful crises in sickle cell disease.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kenneth I Ataga, MD | 919-966-0178 | kataga@med.unc.edu |
| Contact: Susan K Jones, RN | 919-966-6876 | skjones@med.unc.edu |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7305 | |
| Contact: Kenneth I Ataga, MD 919-966-0178 kataga@med.unc.edu | |
| Contact: Susan K Jones, RN 919-966-6876 skjones@med.unc.edu | |
| Principal Investigator: Kenneth I Ataga, MD | |
| Sub-Investigator: Nigel S Key, MD | |
| Sub-Investigator: Leslie V Parise, PhD | |
| Principal Investigator: | Kenneth I Ataga, MD | The University of North Carolina, Chapel Hill |
More Information
| Responsible Party: | University of North Carolina, Chapel Hill, NC ( Kenneth I. Ataga, MD ) |
| Study ID Numbers: | 1 R21 HL091265-01A1 |
| Study First Received: | January 31, 2009 |
| Last Updated: | January 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00834899 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Sickle cell disease Pain crisis Acute pain episode Eptifibatide |
Antiplatelet therapy Safety Treatment |
|
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia Sickle Cell Anemia |
Anemia, Hemolytic Platelet Aggregation Inhibitors Pain Eptifibatide Hemoglobinopathy Anemia, Sickle Cell |
|
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Therapeutic Uses Hemoglobinopathies Hematologic Agents |
Anemia Anemia, Hemolytic Platelet Aggregation Inhibitors Eptifibatide Anemia, Sickle Cell Pharmacologic Actions |
