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Study Title Principal Investigator
Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of Open Label Study With Multiple (and for Non Responders) Escalating Subcutaneous Doses of BI 655064 Once a Week in Patients With Chronic Primary Immune Thrombocytopenic Purpura.
Active, not recruiting | Thrombosis | Multisite
Boehringer Ingelheim
NC-HEM-15-4 A Phase III Double-Blind, Randomized, Parallel Group, Multicenter Placebo-Controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura
Recruiting | Thrombosis | Multisite
Ilene Weitz
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The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects
Completed | Thrombosis | Multisite
Kenji Inaba
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NC-HEM-14-3: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Recruiting | Thrombosis | Multisite
Howard Liebman
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5GYN-15-2-The Safety of Oral Apixaban (Eliquis) versus Subcutaneous Enoxaparin (Lovenox) for Thromboprophylaxis in Women with Suspected Pelvic Malignancy; a Prospective Randomized Open Blinded End-point (PROBE) Design
Apixaban (Eliquis) is an oral anticoagulant for the treatment and prevention of thromboembolic events. It is advantageous as there is no need to perform routine blood monitoring tests including, international normalized ratio (INR), partial thromboplastin time (PTT) and Factor Xa, to determine clotting in participants receiving treatment. Several studies have shown the efficacy of apixaban for the treatment and prevention of VTE. We anticipate that the same efficacy could be replicated in the prevention of VTE in women undergoing surgery for gynecologic cancer. An oral-anticoagulant for standard treatment for prevention of VTE outcomes following surgery could help improve the surgical mortalities associated with gynecologic oncology surgical patients, improve patient adherence for outpatient treatment, and reduce VTE surveillance and outcomes.
| Thrombosis | Not Multisite
Koji Matsuo
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NC-HEM-16-1-A Phase 1/2 Open-Label, Dose Escalation Study of PRTX-100 in Adult Patients with Persistent/Chronic Immune Thrombocytopenia
| Thrombosis | Multisite
Howard Liebman
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NC-HEM-14-2: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Completed | Thrombosis | Multisite
Howard Liebman
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Multicenter, Randomized, Active-Controlled Efficacy and Safety Study Comparing Extended Duration Betrixaban With Standard of Care Enoxaparin for the Prevention of Venous Thromboembolism in Acute Medically Ill Patients
Completed | Thrombosis | Multisite
Santhi Kumar
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NC-HEM-12-4: A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial with an Open-label ExtensionPhase to Evaluate the Efficacy and Safety of Oral E5501 versusEltrombopag, in Adults with Chronic Immune Thrombocytopenia(Idiopathic Thrombocytopenic Purpura)
The study consisted of three phases: Prerandomization, Randomization (Core Study) and Extension Phase. Participants 18 years of age and over, who meet all the eligibility requirements, were randomized into the study. It was required that splenectomized participants made up at least 35% of the study population and no single platelet count was greater than 35x10^9/L. Participants were centrally stratified at randomization by splenectomy status, baseline platelet count, and use of concomitant ITP medication at baseline and were randomized to receive either double-blind avatrombopag or eltrombopag in a 1:1 ratio. Participants received blinded therapy at a starting dose of 20 mg avatrombopag once daily or 50 mg eltrombopag once daily. Participants were allowed to have their dose titrated up (maximum dose 40 mg avatrombopag and 75 mg for eltrombopag) or down (minimum dose 5 mg for avatrombopag and 25 mg for eltrombopag) depending on their response to study drug. The goal of dose modification was to maintain the platelet count at levels greater than or equal to 50x10^9/L and less than or equal to 150x10^9/L, and to decrease the need for ITP-directed concomitant medications. The duration of treatment in the Core study and the Extension Phase is approximately 26 and 104 weeks, respectively.
Terminated | Thrombosis | Not Multisite
Howard Liebman
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A Phase I/II Study of Immunotherapy with Humanized Anti-CD20 Antibody, IMMU-106 (hA20), in Adult Patients with Chronic Immune Thrombocytopenic Purpura
Idiopathic thrombocytopenic purpura (ITP) is a condition in which the patient has very low platelet counts. It is believed that this is caused by the body's own immune system destroying the platelets. Initial treatment is with steroids and if this is not successful, removal of the spleen may be performed. Sometimes, the patient is refractory to all forms of therapy. CD20 is an antigen that is found on B cells. B cells are important in the immune system. Anti-CD20 is an antibody that targets the CD20 site on the B cell and can bind to this site inhibiting an important step in the proliferation of B cells thereby causing a depletion of these cells. The purpose of this study is to determine the optimal dose of the experimental agent IMMU-106 (an anti-CD-20 antibody) in patients with ITP. This is a Phase I/II study in which 3 different doses ( administered twice, 2 weeks apart, intravenously or by subcutaneous injection) will be evaluated for safety and to determine the optimal dose for later studies. An additional dosing schedule with hA20 administered by subcutaneous injection at a dose of 320 mg given once weekly for 4 consecutive weeks has been implemented. Initial subjects will be given infusions of the drug at the lowest of the three doses. If there is no significant toxicity, the next group of subjects will receive a higher dose and if there is again no significant toxicity, the third group will receive the highest dose. The subjects will be monitored for response to the drug, adverse effects, labs, physical exams, medical status and EKGs.
Active, not recruiting | Thrombosis | Multisite
Howard Liebman
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NC-HEM-14-6: Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 (Anti-CD40L dAb) in Adult Subjects with Primary Immune Thrombocytopenia (ITP)
Recruiting | Thrombosis | Multisite
Howard Liebman
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NC-HEM-11-1: A PHASE II, SINGLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED TRIAL TO STUDY THE EFFICACY AND SAFETY OF ANTI-VON WILLEBRAND FACTOR NANOBODY ADMINISTERED AS ADJUNCTIVE TREATMENT TO PATIENTS WITH ACQUIRED THROMBOTIC THROMBOCYTOPENIC PURPURA
Completed | Thrombosis | Multisite
Ilene Weitz
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