Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study Safety and Efficacy of Danaparoid vs Argatroban

Stopped early · Phase 3

Conditions studied: Heparin-induced Thrombocytopenia

In brief

An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

Key facts

Study ID

NCT03809481

Run by

Aspen Global Incorporated

People needed

7

Starts

2019-05-16

Expected to finish

2022-06-10

Last updated by the study team

2022-12-08

Who can join

Age: 0 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• At the time of enrollmentsubjects are excluded from the study if any of the following criteria apply:
• Premature infants (corrected age <37 weeks gestational age)
• Subjects undergoing Extracorporeal Membrane Oxygenation (ECMO) treatment
• Fibrinolytic therapy <24 hours before enrollment
• Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
• Severe hepatic impairment (Child-Pugh Class C) Note: in patients with suspected/confirmed severe liver disease, Child-Pugh C stage of liver disease must be excluded before start of treatment. For calculating Child-Pugh score, laboratory parameters in the patient file on INR, prothrombin time, serum albumin and total bilirubin taken can be taken, if they have been obtained within the last 48 hours before randomization. In all other patients these parameters have to be measured before start of treatment to identify potential exclusion criteria.
• Active bleeding
• Subjects with the following conditions to be excluded if alternative antithrombotic treatments are available:
• (i) Severe hemorrhagic diathesis, (ii) Traumatic damage to the central nervous system (iii) Brain, spinal or ophthalmologic surgery (iv) Active stomach/duodenal ulcers or active peptic ulcer unless this ulcer is the cause of the surgical procedure
• An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range
• A hemorrhagic cerebrovascular accident within the previous 3 months
• Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg
• Diabetic retinopathy
• Acute bacterial endocarditis
• Expectation of a long-term (> 3 weeks) hemodialysis requirement before the end of the acute treatment
• Hypersensitivity to the active substances or to any of the excipients
• Hypersensitivity to sulphite
• Any investigational drug(s) use within 4 weeks preceding screening or anticipated use during the course of the study
• Pregnant or breastfeeding woman
• Use of intra-aortic balloon pump, or ventricular assist device
• Use of any non-heparin anticoagulant treatment for suspected HIT for more than 48 hours before enrollment.

Where it is running

• Shands University of Florida — Gainesville, Florida, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Clinical Center of the Republic of Srpska, Medical Intesnive Care Unit — Banja Luka, Republika Srpska, Bosnia and Herzegovina
• University Clinical Centre of the Republic of Srpska, Clinic for cardiology — Banja Luka, Bosnia and Herzegovina
• University Clinical Centre of the Republic of Srpska, Lung Clinic — Banja Luka, Bosnia and Herzegovina
• Clinical Center University of Sarajevo, Clinic for Heart, Blood Vessels and Rheumatic Diseases — Sarajevo, Bosnia and Herzegovina
• Clinical Center University of Sarajevo, Clinic for Lung Diseases — Sarajevo, Bosnia and Herzegovina
• Jewish General Hospital — Montreal, Canada
• CHU St Etienne; Avenue Albert Raimond — Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France
• DIJON University Hospital — Dijon, Burgundy, France
• Centre Hospitalier Universitaire Amiens Picardie — Amiens, Somme, France
• Vivantes Klinikum im Friedrichhain Hämophiliezentrum, Gerinnungssprechstunde Landsberger Allee 49 — Berlin, Berlin-Brandenburg, Germany
• Universitätsklinikum Gießen und Marburg GmbH, Klinik für Herz-, Kinderherz- und Gefäßchirurgie Standort Gießen — Giesen, Lower Saxony, Germany
• Städtisches Klinkum Dresden — Dresden, Saxony, Germany
• Universitatstklinikum Halle (Saale), Medizinische Klinik III — Halle, Saxony-Anhalt, Germany
• University Hospital Greifswald Dpt. of Hematology — Greifswald, Germany
• Zentrum für Klinische Transfusionsmedizin — Tübingen, Germany
• Azienda Ospedaliero Universitaria S.Orsola-Malpighi - UO Angiologia e Malattie della Coagulazione — Bologna, Emilia-Romagna, Italy
• AOU Careggi, SOD Malattie Aterotrombotiche — Florence, Florence, Italy
• ASST Papa Giovanni XIII, Servizio di Immunoematologia e Medicina Trasfusionale — Bergamo, Lombardy, Italy
• Instituto Scientifico San Raffaele- Servizio Coagulazione e Centro Trombosi — Milan, Italy
• Centrum Medyczne HCP Sp. z o.o. Szpital im. Św. Jana Pawła II — Poznan, Poland

Full record on ClinicalTrials.gov

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