Heparin-induced Thrombocytopenia
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CLINICAL_TRIALS trial_result · 2025-11-25Clinical Trial Update: A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia [Phase 2]
A Phase 2 study evaluating VLX-1005 versus placebo for suspected heparin-induced thrombocytopenia was terminated.
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CLINICAL_TRIALS research · 2025-05-25Clinical Trial Update: Characterization and Quantification of Platelet/Leukocyte Aggregates in Patients With Suspected Heparin-induced Thrombocytopenia [NA]
This clinical trial is recruiting to characterize and quantify platelet/leukocyte aggregates in patients with suspected heparin-induced thro…
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CLINICAL_TRIALS other · 2024-06-27Clinical Trial Update: Pharmacogenomics of Heparin-Induced Thrombocytopenia
This clinical trial update concerns pharmacogenomic research in the development or management of heparin-induced thrombocytopenia; the study…
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FDA approval · 2023-08-01FDA Approved: ARGATROBAN — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for Argatroban from Mylan Institutional LLC under ANDA 202626, expanding the use of this generic…
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FDA approval · 2023-07-31FDA Approved: ARGATROBAN — Original Application (Mullan Pharmaceutical Inc.)
The FDA approved a generic version of argatroban from Mullan Pharmaceutical Inc. for anticoagulation in patients with heparin-induced thromb…
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CLINICAL_TRIALS trial_result · 2022-12-08Clinical Trial Update: Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban [Phase 3]
Phase 3 trial comparing danaparoid to argatroban in heparin-induced thrombocytopenia was terminated.
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FDA approval · 2021-06-07FDA Approved: ARGATROBAN — Original Application (Accord Healthcare Inc.)
FDA approved Accord Healthcare Inc.'s original application for argatroban, authorizing its use as an anticoagulant for heparin-induced throm…
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FDA approval · 2021-01-21FDA Approved: ARGATROBAN — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA's Argatroban under an Original Application (ANDA214235), making a generic direct thrombin inhibitor availabl…
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CLINICAL_TRIALS trial_result · 2020-12-23Clinical Trial Update: Efficacy and Safety of Apixaban in the Treatment of Heparin Induced Thrombocytopenia (HIT) [Phase 2]
Phase 2 trial evaluating apixaban for efficacy and safety in heparin-induced thrombocytopenia (HIT); study terminated with results posted.
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CLINICAL_TRIALS withdrawal · 2020-10-19Clinical Trial Update: Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients [Phase 4]
Phase 4 trial evaluating bivalirudin in HIT/HITTS has been withdrawn.
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CLINICAL_TRIALS withdrawal · 2019-08-13Clinical Trial Update: Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT) [Phase 4]
A Phase 4 trial evaluating fondaparinux in patients with heparin-induced thrombocytopenia was withdrawn.
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FDA approval · 2018-12-21FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)
The FDA approved a supplemental application for BIVALIRUDIN from Civica, Inc., resulting in an approved update to the NDA.
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FDA approval · 2018-11-27FDA Approved: ARGATROBAN — Original Application (Eugia US LLC)
FDA approved Argatroban under an Original Application (NDA209552) by Eugia US LLC, establishing its use as a direct thrombin inhibitor for p…
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CLINICAL_TRIALS trial_result · 2018-08-15Clinical Trial Update: Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT) [Phase 3]
A multi-center single-arm Phase 3 trial evaluating the effectiveness of varying warfarin therapy duration in patients with heparin-induced t…
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FDA approval · 2018-07-27FDA Approved: BIVALIRUDIN — Original Application (Eugia US LLC)
FDA approved the original application for BIVALIRUDIN by Eugia US LLC, granting a generic version of the anticoagulant for approved indicati…
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FDA approval · 2018-06-01FDA Approved: BIVALIRUDIN — Original Application (Mylan Institutional LLC)
FDA approved the original abbreviated new drug application for bivalirudin from Mylan Institutional LLC, enabling the marketing of a generic…
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CLINICAL_TRIALS research · 2017-08-31Clinical Trial Update: Thrombotic Biomarkers to Predict Thrombosis in Heparin-induced Thrombocytopenia
This clinical trial update discusses using thrombotic biomarkers to predict thrombosis risk in patients with heparin-induced thrombocytopeni…
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FDA approval · 2017-05-22FDA Approved: ARGATROBAN — Original Application (Gland Pharma Limited)
FDA approved a generic injectable anticoagulant Argatroban from Gland Pharma Limited under Original Application (ANDA205570) for use in adul…
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CLINICAL_TRIALS trial_result · 2016-06-30Clinical Trial Update: Rapid Diagnosis of Heparin-Induced Thrombocytopenia in Surgical Critically Ill Patients
The study evaluating rapid diagnosis of heparin-induced thrombocytopenia in surgical critically ill patients has completed.
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FDA label_change · 2016-05-26FDA Approved: ARGATROBAN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Argatroban to update the product labeling. The change was submitted by Hikma Pharmaceuticals USA…
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FDA approval · 2016-05-25FDA Approved: ARGATROBAN — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Argatroban from Fresenius Kabi USA, LLC. This action constitutes a supplemental approval rather …
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CLINICAL_TRIALS trial_result · 2016-03-25Clinical Trial Update: Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia [Phase 3]
A Phase 3 clinical trial evaluating rivaroxaban for treatment of suspected or confirmed heparin-induced thrombocytopenia has been terminated…
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FDA approval · 2016-03-21FDA Approved: BIVALIRUDIN — Supplemental Application (Civica, Inc.)
FDA approved a Civica, Inc.-submitted supplemental application for Bivalirudin, updating its regulatory status for use as an anticoagulant. …
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CLINICAL_TRIALS trial_result · 2015-12-22Clinical Trial Update: Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II [Phase 2]
Phase 2 study evaluating argatroban for management of heparin-induced thrombocytopenia type II; results posted.
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CLINICAL_TRIALS trial_result · 2015-05-04Clinical Trial Update: Heparin-Induced Thrombocytopenia - Retrospective Analysis of Data on Incidence and Outcomes Study
A retrospective analysis assessing the incidence and outcomes of heparin-induced thrombocytopenia.