Status:
COMPLETED
Safety and Dosing Evaluation of REG1 Anticoagulation System
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Healthy
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This 1-week study will test the safety and dosing of an anticoagulation system called REG1 that is designed to improve control of "blood thinning." Patients with heart attack and other conditions requ...
Detailed Description
Given the central role of thrombosis in the pathobiology of acute ischemic heart disease, injectable (intravenous or subcutaneous) anticoagulants have become the foundation of medical treatment for pa...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participants are eligible if they meet the following criteria:
- Age is greater than or equal to 21 years to 65 years
- Ability to give written informed consent
- Weight between 50 Kg and 120 Kg
- EXCLUSION CRITERIA:
- Participants are NOT eligible under the following conditions:
- Age is less than 21 years
- Subject weight is less than 50 Kg of greater than 120 Kg
- Females - Pregnant or lactating
- Females - active menstruation on day of injection (Females may be randomized if they are not actively menstruating on day of injection or they can be randomized as soon as menstruation ceases)
- Any medical condition (other than a self-limited illness) that requires ongoing and current medical attention
- Any prescription medication (including oral or patch or injectable contraceptives)
- Any use of NSAIDS or aspirin in the prior 7 days
- Any known individual or family history of a bleeding diathesis or coagulopathy
- Any history of thrombocytopenia, or baseline platelet count less than 150,000
- Any history of thrombocytosis or baseline platelet count greater than 600,000
- Endoscopic peptic ulcer disease in the past 3 years or GI bleeding in the past 3 months
- Genitourinary bleeding within the past 3 months
- Severe trauma, fracture, major surgery, or biopsy of a parenchymal organ within the past 3 months
- Any evidence or history of intracranial bleeding or aneurysm
- Any history of thrombotic or hemorrhagic stroke
- Severe persistent hypertension (systolic pressure greater than 180 mm Hg or diastolic greater than 110 mm Hg)
- Baseline Hgb less than 12.0 g/dL, PT greater than ULN, or APTT greater than ULN
- Baseline liver dysfunction (ALT, AST, bilirubin, or alkaline phosphatase greater than ULN)
- Baseline renal dysfunction (serum creatinine or BUN greater than ULN)
- Use of an investigational drug within the past 30 days
- Any factor that might influence ability to return for follow-up visits
- Illicit drug or alcohol abuse
- Inability to comply with the study protocol
Exclusion
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00113997
Start Date
June 1 2005
End Date
October 1 2005
Last Update
March 4 2008
Active Locations (1)
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1
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892