Acute Heparin-induced Thrombocytopenia (HIT) MedDRA version: 20.0 Level: PT Classification code 10062506 Term: Heparin-induced thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: Orgaran,750 anti-Xa units/0.6ml, Solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Danaparaoid sodium
Sponsors
Aspen Global Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of enrolment 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, or if the subject is unable to do so, then consent will be sought from a family member, or a legally accepted representative 2. Males or females aged =2 weeks 3. Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of at least 30% between day 4 and 14 of heparin exposure or 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: Glomerular filtration rate = 15 mL/min 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: A female participant is eligible to participate if 1 of the following conditions applies: a. Not a woman of childbearing potential OR b. A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days corresponding to time needed to eliminate study intervention. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for = 3 months prior to entry into the study.) 7. Understanding/willingness by the subject or his/her legally accepted representative to participate in the clinical study and ability to comply with study procedures and the study visit schedule Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 486 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: At the time of enrolment subjects are excluded from the study if any of the following criteria apply: 1. Premature infants (corrected age 2 x the normal range 9. Any cerebrovascular accident within the previous 3 months or has a history of haemorrhagic cerebrovascular incidence 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) haemodialysis 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that for the treatment of subjects with acute heparin-induced thrombocytopenia (HIT) danaparoid use is not inferior to argatroban in terms of efficacy. ; Secondary Objective: To collect additional efficacy data To describe the safety of danaparoid in comparison to argatroban ; Primary end point(s): The primary efficacy endpoint (composite endpoint) is defined as treatment response at Day 44. A subject will be considered a treatment responder, if none of the following events occur by Day 44: • New or extended venous and/or arterial thrombosis, including gangrene/skin necrosis Note: ‘thrombosis’ denotes venous and/or arterial here and throughout the protocol • All-cause mortality • Unplanned amputation, including ischaemic gut resection ;Timepoint(s) of evaluation of this end point: Day 44 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary • Percentage of subjects with consistent increases in platelets at days 3, 5, and 7 (evidence of early response), defined as monotonically increasing platelet counts, measured 2 days apart on days 3 (±1 day), 5 (±1 day) and 7 (±1 day). • Deaths due to TE or bleeding up until Day 44 • Incidence of fatal or non-fatal major bleeding up until Day 44 Note: As outlined by the Control of Anticoagulation Subcommittee major bleeding in non-surgical patients is defined as: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or 3. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/ L) or more, or leading to transfusion of two or more units of whole blood or red cells • New or extended thrombosis, including gangrene/skin necrosis • Unplanned amputation, including ischaemic gut resection • All-cause mortality Exploratory • Time to first event (new/extended thrombosis, all cause mortality, unplanned amputation) • Time to reach consistent increase in 3 consecutive alternate day platelet count measurements during acute treatment • Incidence of new or extended TE events, including gangrene/skin necrosis up until Day 14 • Incidence of all-cause mortality up until Day 14 • Incidence of unplanned amputation up until Day 14 • Incidence of fatal or non-fatal major bleeding up until Day 14 • All-cause mortality • Incidence of fatal and non-fatal major bleeding events (as defined above) during the acute treatment and then the entire follow-up period (until Day 44) | — |
Countries
Bosnia and Herzegovina, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Hungary, Italy, Poland, Russian Federation, Serbia, Spain, United States
Contacts
Public ContactBenjamin Graziani
Ergomed
Outcome results
None listed