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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR ARGATROBAN

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Clinical Trials for Argatroban

Trial ID Title Status Sponsor Phase Summary
NCT00035178 Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis Completed Texas Biotechnology Corporation Phase 4 The primary goals of this investigation are to provide guidance on how to dose Argatroban in patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in hemodialysis patients. The secondary goal of the study will be to assess the adequacy of anticoagulation during hemodialysis.
NCT00039858 Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Completed GlaxoSmithKline Phase 4 The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00039858 Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Completed Encysive Pharmaceuticals Phase 4 The purpose of this study is to evaluate the safe and effective dose of Argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.
NCT00113997 Safety and Dosing Evaluation of REG1 Anticoagulation System Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 1 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Argatroban

Condition Name

Condition Name for Argatroban
Intervention Trials
Heparin-Induced Thrombocytopenia 2
CVD 2
Ischemic Stroke 2
Stroke 2
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Condition MeSH

Condition MeSH for Argatroban
Intervention Trials
Thrombocytopenia 7
Stroke 5
Thrombosis 4
Ischemia 3
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Clinical Trial Locations for Argatroban

Trials by Country

Trials by Country for Argatroban
Location Trials
United States 38
Japan 12
China 4
Germany 2
Belgium 2
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Trials by US State

Trials by US State for Argatroban
Location Trials
Texas 4
Illinois 3
Massachusetts 3
Ohio 2
Michigan 2
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Clinical Trial Progress for Argatroban

Clinical Trial Phase

Clinical Trial Phase for Argatroban
Clinical Trial Phase Trials
Phase 4 11
Phase 3 1
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Argatroban
Clinical Trial Phase Trials
Completed 13
Terminated 4
Recruiting 4
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Clinical Trial Sponsors for Argatroban

Sponsor Name

Sponsor Name for Argatroban
Sponsor Trials
GlaxoSmithKline 3
Mitsubishi Tanabe Pharma Corporation 3
The University of Texas Health Science Center, Houston 3
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Sponsor Type

Sponsor Type for Argatroban
Sponsor Trials
Other 18
Industry 10
NIH 1
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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Chubb
UBS
Cerilliant
McKesson
Fish and Richardson
Citi
Johnson and Johnson

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