Heparin induced thrombocytopenia (HIT) Type II MedDRA version: 9.1 Level: LLT Classification code 10048672 Term: Heparin-induced thrombocytopenia type II
Conditions
Interventions
Trade Name: Novastan 100 mg/ml concentrate for solution for infusion
Product Name: Argatroban
Product Code: MCI-9038
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ARG
Sponsors
Mitsubishi Tanabe Pharma Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged = 18 years 2. Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study 3. Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation 4. Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled bleeding 2. Severe hepatic impairment (Child-Pugh Class C) 3. Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol) 4. Pregnancy (exclusion by routine urine test) 5. Lactating woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect data on the clinical management of argatroban in subjects with heparin induced thrombocytopenia Type II who require parenteral antithrombotic therapy in France. The population is most likely to include patients with suspected or confirmed heparin-induced thrombocytopenia Type II in whom the treating physician considers therapy with argatroban to be optimal including but not limited to those subjects with: - renal impairment with or without mild to moderate hepatic impairment - patients over 65 years of age - patients who cannot receive danaparoid or lepirudin - controllable haemorrhagic risk and mild moderate or severe renal impairment ;Secondary Objective: Not Applicable;Primary end point(s): Clinical Evaluations: - composite of all-cause death, thrombosis (new and extended) and unplanned amputation - all-cause death - death related to HIT - thrombosis (new and extended) - unplanned amputation - major / minor bleeding Laboratory Evaluations: - platelet counts (recovery – speed and extent) - aPTT, ECT and TT (onset and maintenance) - D-dimer, Thrombin generation Test (TGT), Prothrombin Fragnment F1.2 and microparticles - plasma concentration of argatroban in relation to aPTT, ECT and TT | — |
Countries
France
Outcome results
None listed