Trial Outcomes & Findings for A Safety Study of Eptifibatide in Patients With Sickle Cell Disease (NCT NCT00834899)
NCT ID: NCT00834899
Last Updated: 2013-06-27
Results Overview
Change in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Up to 35 days
Results posted on
2013-06-27
Participant Flow
Patients with sickle cell disease, admitted with an acute pain episode, and who met eligibility criteria were approached to participate.
Patient who agreed to participate provided informed consent and were screened for eligibility. Eligible patients were subsequently randomized to treatment with eptifibatide or placebo.
Participant milestones
| Measure |
Eptifibatide
Patients randomized to the eptifibatide arm received 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.
|
Placebo
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
|
Overall Study
COMPLETED
|
8
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Eptifibatide
Patients randomized to the eptifibatide arm received 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.
|
Placebo
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Safety Study of Eptifibatide in Patients With Sickle Cell Disease
Baseline characteristics by cohort
| Measure |
Eptifibatide
n=9 Participants
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 Participants
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
30.6 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
34.0 years
STANDARD_DEVIATION 12.19 • n=7 Participants
|
31.6 years
STANDARD_DEVIATION 9.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 35 daysPopulation: Intention to treat
Major bleeding episodes are defined as any episode, such as gastrointestinal bleeding or intracranial bleed that typically leads to hospitalization or other prolonged bleeding requiring a blood transfusion
Outcome measures
| Measure |
Eptifibatide
n=9 Participants
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 Participants
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
1) Major Bleeding Episodes
|
0 participants
Interval -0.604 to 0.372
|
0 participants
Interval -0.604 to 0.372
|
PRIMARY outcome
Timeframe: Up to 35 daysChange in platelet counts occurring anytime from randomization up to day 35 (final follow-up visit).
Outcome measures
| Measure |
Eptifibatide
n=9 Participants
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 Participants
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Change in Platelet Count
|
97 x 10^9/L
Interval -50.0 to 410.0
|
-5 x 10^9/L
Interval -63.0 to 129.0
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Intention to treat
The duration of the pain episode will be defined as the time from randomization to termination of the pain episode. The pain episode will be considered terminated when the patient states that the crisis is resolved (defined as being ready to go home on oral analgesics) or all of the following criteria are met: 1. Pain relief (pain scores ≤ 40) maintained for at least 2 consecutive readings (assessed using a visual analog scale with measurements from 0 - 100, where 0 is no pain and 100 is worst imaginable pain). 2. No parenteral analgesics have been administered for at least 12 hours. 3. Ability to walk normally (unless he/she was unable to walk for some other reason prior to the crisis onset).
Outcome measures
| Measure |
Eptifibatide
n=9 Participants
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 Participants
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Effect of Eptifibatide on Duration of Acute Pain Episodes
|
3.0 Days
Interval 1.81 to 8.0
|
3.0 Days
Interval 0.08 to 3.92
|
SECONDARY outcome
Timeframe: Up to 7 daysPopulation: Intention to treat
The duration of hospitalization will be defined as the period from randomization to the time an order for discharge from the hospital is written.
Outcome measures
| Measure |
Eptifibatide
n=9 Participants
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 Participants
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Effect of Eptifibatide on Duration of Hospitalization
|
3.0 Days
Interval 2.0 to 36.1
|
3.0 Days
Interval 2.0 to 4.0
|
Adverse Events
Eptifibatide
Serious events: 8 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eptifibatide
n=9 participants at risk
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 participants at risk
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adenovirus Respiratory Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Bacteremia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Hypoxemia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain, Left
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain, Right
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Sickle Cell Crisis, recurrent
|
33.3%
3/9 • Number of events 4
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Worsening anemia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Cardiac disorders
Acute Chest Syndrome
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
Other adverse events
| Measure |
Eptifibatide
n=9 participants at risk
Patients randomized to the eptifibatide arm received 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.
|
Placebo
n=4 participants at risk
Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
|
|---|---|---|
|
General disorders
Ankle Swelling, bilateral
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Excessive perspiration
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Headache
|
55.6%
5/9 • Number of events 5
|
50.0%
2/4 • Number of events 3
|
|
Nervous system disorders
Headache, recurrent
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Vascular disorders
Infusion site extravasation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
|
Nervous system disorders
Lightheadedness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Nausea
|
33.3%
3/9 • Number of events 3
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Nosebleed
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Possible Acute Chest Syndrome
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Reticulocytosis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Sickle Cell Crisis, recurrent
|
22.2%
2/9 • Number of events 2
|
25.0%
1/4 • Number of events 1
|
|
Blood and lymphatic system disorders
Sickle Cell Crisis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
General disorders
Sore Throat
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
22.2%
2/9 • Number of events 2
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/9
|
25.0%
1/4 • Number of events 1
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/9
|
25.0%
1/4 • Number of events 2
|
|
Renal and urinary disorders
Urinary Tract Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1
|
0.00%
0/4
|
Additional Information
Kenneth I. Ataga, MD
University of North Carolina at Chapel Hill
Phone: 919-966-0178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place