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Last Updated: October 31, 2020

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CLINICAL TRIALS PROFILE FOR THROMBIN-JMI

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All Clinical Trials for THROMBIN-JMI

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000612 Soy Estrogen Alternative Study (SEA) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1996-01-01 To conduct a three-armed trial assessing the effect of soy phytoestrogens on menopausal complaints, plasma lipids and lipoproteins, vaginal bleeding and endometrial proliferation, and health related quality of life.
NCT00039767 Heparin Versus Lepirudin Flushes in Preventing Blockage of Venous Access Devices Completed National Institutes of Health Clinical Center (CC) Phase 2 2002-05-01 This study will compare the effectiveness of two blood thinners, heparin and lepirudin, in preventing withdrawal occlusion (blockage) in a venous access device (VAD). A VAD is a catheter (plastic tube) placed in a vein beneath the collarbone to deliver medication and withdraw blood samples during treatment. The device may become clogged, possibly by formation of a clot around the tip, blocking its opening and making it difficult or impossible to use. The clot can be dissolved by a medication called tPA. The blood thinner heparin has been used for many years to try to prevent the blockage from occurring, but it is still a problem in as many as 25 percent of VADs. This study will test whether a new blood thinner called lepirudin is more effective than heparin in preventing withdrawal occlusion caused by a small clot. Patients 21 years of age and older who are enrolled in NIH protocols at the Clinical Center and who require tunneled, open-ended VADs for their medical care may be eligible for this study. Candidates must expect to receive all of their primary medical care at the Clinical Center during the first 4 weeks after their VAD is inserted and most of their care at the Clinical Center for the next 3 months. Participants will be randomly assigned to receive either heparin or lepirudin flushes for the first 3 or 4 weeks after placement of their VAD-the period during which withdrawal occlusion is most likely to occur. After this period, all patients will use routine heparin flushes until the VAD is removed. The patient's VAD will be closely monitored for withdrawal occlusion during the 3- to 4-week test period and will continue to be observed for up to 3 months to check for lasting effects of the blood thinner.
NCT00113997 Safety and Dosing Evaluation of REG1 Anticoagulation System Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 2005-06-01 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 require treatment with an anticoagulant (blood thinner) to prevent the formation of blood clots. However, anticoagulation therapy can increase the risk of bleeding. The REG1 system is designed to minimize this risk. One part of the system stops the activity of factor IX (a protein that helps blood clot) while the other part of the system (the antidote) inactivates the drug and stops the thinning process. This study will examine in normal healthy subjects how the REG1 system works in the body and how it leaves the body. Healthy normal volunteers between 12 and 65 years of age who weigh 50-120 kilograms (110-264 pounds) and have no history of bleeding problems or significant bleeding may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants must avoid foods that may alter the blood's clotting ability and must not take any medications the week of the study. They undergo the following tests and procedures: Day 1 Subjects are admitted to the NIH Clinical Center for an overnight stay. Two catheters (plastic tubes) are placed in the subject's arm veins, one for drawing blood samples and the other for injecting one of the following: REG1 drug, REG1 antidote, REG1 drug and antidote, or placebo. Two injections of study medication are given, spaced 3 hours apart, each over a 1-minute period. After each injection, blood is collected at specific times to measure levels of the drug or antidote in the body and the blood's ability to clot. Subjects also provide a 24-hour urine collection and stool sample. Day 2 A blood sample is drawn 24 hours after the drug or antidote injection from the previous day. If the blood test result is normal, subjects are discharged home with instructions to follow. They return to the Clinical Center at 36 hours and 48 hours for additional blood samples. Days 3 and 7 A blood sample is collected at the end of day 3 and day 7. Urine and stool samples are also collected.
NCT00116012 Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32 Completed The TIMI Study Group Phase 2 2005-06-01 The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission). After completion of the ascending dose-ranging part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB), the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin (UFH).
NCT00116012 Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32 Completed ARCA Biopharma, Inc. Phase 2 2005-06-01 The primary focus of this study is to explore the safety of a range of doses of rNAPc2 in subjects who are managed in hospitals that most typically practice an early invasive strategy (catheterization during the index admission). After completion of the ascending dose-ranging part of the trial and review of these data by the Data and Safety Monitoring Board (DSMB), the maximum tolerated dose of rNAPc2 will be studied in single-arm, open-label panels (approximately 25 subjects each) of rNAPc2 with descending doses of unfractionated heparin (UFH).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for THROMBIN-JMI

Condition Name

Condition Name for THROMBIN-JMI
Intervention Trials
Coronary Artery Disease 19
Atrial Fibrillation 15
Venous Thromboembolism 8
Bleeding 8
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Condition MeSH

Condition MeSH for THROMBIN-JMI
Intervention Trials
Coronary Artery Disease 27
Coronary Disease 26
Atrial Fibrillation 23
Myocardial Ischemia 23
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Clinical Trial Locations for THROMBIN-JMI

Trials by Country

Trials by Country for THROMBIN-JMI
Location Trials
United States 217
Canada 37
Germany 17
Italy 16
China 14
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Trials by US State

Trials by US State for THROMBIN-JMI
Location Trials
Florida 13
Maryland 13
North Carolina 12
Texas 12
New York 11
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Clinical Trial Progress for THROMBIN-JMI

Clinical Trial Phase

Clinical Trial Phase for THROMBIN-JMI
Clinical Trial Phase Trials
Phase 4 86
Phase 3 35
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for THROMBIN-JMI
Clinical Trial Phase Trials
Completed 82
Recruiting 60
Not yet recruiting 36
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Clinical Trial Sponsors for THROMBIN-JMI

Sponsor Name

Sponsor Name for THROMBIN-JMI
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 9
Merck Sharp & Dohme Corp. 8
Boehringer Ingelheim 7
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Sponsor Type

Sponsor Type for THROMBIN-JMI
Sponsor Trials
Other 262
Industry 81
NIH 14
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