Heparin-induced Thrombocytopenia Clinical Trial
— HITSOVAOfficial title:
Open-Label, Randomised, Active Controlled, Multi-Centre Ph 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Acute HIT
Verified date | December 2022 |
Source | Aspen Global Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Terminated |
Enrollment | 7 |
Est. completion date | June 10, 2022 |
Est. primary completion date | June 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Weeks to 100 Years |
Eligibility | At the time of enrollment subjects are eligible to be included in the study only if all of the following criteria apply: 1. Signed written informed consent by the subject who is able to assess the nature, significance and scope of the clinical trial. If the subject is in emergency situation and temporarily incapable of consent, the consent of a legal representative or authorized representative will be waived if permitted under applicable local regulations/ethics committee recommendations. Consent must be obtained for further participation in the clinical trial as soon as this is possible and reasonable for the subject to do so to confirm understanding/willingness to participate in the clinical study and ability to comply with study procedures and the study visit schedule. 2. Males or females aged =2 weeks 3. Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of = 30% at either: 1. Between Day 4 and 14 of the start of heparin exposure or 2. At Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis. 4. Have adequate renal function: estimated glomerular filtration rate (eeGFR) = 15 mL/min/1.73 m² 5. Male participants: A male participant must agree to use contraception during the treatment period and for at least 5 days after the last dose of study intervention and refrain from donating sperm during this period. 6. Female participants: female participant is eligible to participate if 1 of the following conditions applies: Not a woman of childbearing potential or A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and during the entire VKA use and for one month after cessation of its use. Subjects should continue with adequate contraception after the study end if they continue with VKA use. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for = 3 months prior to entry into the study.) Exclusion Criteria: At the time of enrollmentsubjects are excluded from the study if any of the following criteria apply: 1. Premature infants (corrected age <37 weeks gestational age) 2. Subjects undergoing Extracorporeal Membrane Oxygenation (ECMO) treatment 3. Fibrinolytic therapy <24 hours before enrollment 4. Lumbar puncture or spinal/epidural catheter placement within the past 48 hours 5. 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. 6. Active bleeding 7. 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 8. An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range 9. A hemorrhagic cerebrovascular accident within the previous 3 months 10. Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg 11. Diabetic retinopathy 12. Acute bacterial endocarditis 13. Expectation of a long-term (> 3 weeks) hemodialysis requirement before the end of the acute treatment 14. Hypersensitivity to the active substances or to any of the excipients 15. Hypersensitivity to sulphite 16. Any investigational drug(s) use within 4 weeks preceding screening or anticipated use during the course of the study 17. Pregnant or breastfeeding woman 18. Use of intra-aortic balloon pump, or ventricular assist device 19. Use of any non-heparin anticoagulant treatment for suspected HIT for more than 48 hours before enrollment. |
Country | Name | City | State |
---|---|---|---|
Bosnia and Herzegovina | 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 | |
Canada | Jewish General Hospital | Montréal | |
France | Centre Hospitalier Universitaire Amiens Picardie | Amiens | Somme |
France | DIJON University Hospital | Dijon | Burgundy |
France | CHU St Etienne; Avenue Albert Raimond | Saint-Priest-en-Jarez | Rhone- Alpes |
Germany | Vivantes Klinikum im Friedrichhain Hämophiliezentrum, Gerinnungssprechstunde Landsberger Allee 49 | Berlin | Berlin-Brandenburg |
Germany | Städtisches Klinkum Dresden | Dresden | Saxony |
Germany | Universitätsklinikum Gießen und Marburg GmbH, Klinik für Herz-, Kinderherz- und Gefäßchirurgie Standort Gießen | Giesen | Lower Saxony |
Germany | University Hospital Greifswald Dpt. of Hematology | Greifswald | |
Germany | Universitatstklinikum Halle (Saale), Medizinische Klinik III | Halle (Saale) | Saxony-Anhalt |
Germany | Zentrum für Klinische Transfusionsmedizin | Tübingen | |
Italy | ASST Papa Giovanni XIII, Servizio di Immunoematologia e Medicina Trasfusionale | Bergamo | Lombardy |
Italy | Azienda Ospedaliero Universitaria S.Orsola-Malpighi - UO Angiologia e Malattie della Coagulazione | Bologna | Emilia-Romagna |
Italy | AOU Careggi, SOD Malattie Aterotrombotiche | Firenze | Florence |
Italy | Instituto Scientifico San Raffaele- Servizio Coagulazione e Centro Trombosi | Milano | |
Poland | Centrum Medyczne HCP Sp. z o.o. Szpital im. Sw. Jana Pawla II | Poznan | |
Poland | Wojewódzki Szpital Zespolony im. L. Rydygiera | Torun | |
Russian Federation | First City Hospital N.A. E.E. Volosevich | Arkhangelsk | |
Russian Federation | Moscow City Hospital 67 | Moscow | |
Russian Federation | Oncology Center | Omsk | |
Russian Federation | Regional Hospital after N.N Burdenko | Penza | |
Russian Federation | Clinical Hospital ? 122 N. A. L.G. Sokolov | Saint Petersburg | |
Serbia | Clinical Centre of Serbia, Clinic for Emergency Internal Medicine | Belgrade | |
Serbia | Clinical centre of Serbia, Clinic for Pulmonology | Belgrade | |
Serbia | Instiute of Cardiovascular Diseases "Dedinje" | Belgrade | |
Serbia | The Institute for Pulmonary Disease of Vojvodina, Pulmonary thromboembolism department | Novi Sad | Sremska Kamenica |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Shands University of Florida | Gainesville | Florida |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Aspen Global Incorporated |
United States, Bosnia and Herzegovina, Canada, France, Germany, Italy, Poland, Russian Federation, Serbia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Efficacy Response | Efficacy will be assessed by the number of subjects with suspected HIT who respond to treatment. A responder is defined as a subject who has not experienced any of the following from Day 1 to Day 44:
New or extended venous and/or arterial thrombosis, including gangrene/skin necrosis All-cause mortality Unplanned amputation, including ischemic gut resection Efficacy endpoints as defined above will be assessed by clinical exam with special attention to assessments for thromboses, gangrene, and skin necrosis. Clinically suspected thrombosis will be confirmed/ruled out by objective measures, e.g. compression ultrasound. |
Day 44 | |
Secondary | Consistent increases in platelet count | Percentage of subjects with increase in platelet count to values = 100,000/ µL | Days 14 | |
Secondary | Death due to TE or bleeding | Death due to TE or bleeding | Day 44 | |
Secondary | Major Bleeding | Incidence of fatal or non-fatal major bleeding | Day 44 | |
Secondary | New or extended thrombosis | New of extended thrombosis, including gangrene/skin necrosis | Day 44 | |
Secondary | Unplanned amputation | Unplanned amputation, including ischemic gut resection | Day 44 | |
Secondary | All-cause mortality | All-cause mortality | Day 44 |
Status | Clinical Trial | Phase | |
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