To evaluate the effects of VLX-1005
compared to placebo on platelet count
recovery, an important clinical outcome in patients with positive serotonin release assay (SRA+) confirmed HIT, on a
background of standard of care (SoC)
anticoagulation -To evaluate the effects of VLX-1005 compared to placebo on platelet count
recovery, an important clinical outcome in patients with positive serotonin release assay (SRA+) confirmed HIT, on a
background of standard of care (SoC)
anticoagulation
-Time to platelet count recovery; defined as the time from the first dose of study drug to the time of the first of 2 consecutive platelet count recoveries to greater than or equal to150 X 109/L To evaluate the efficacy of VLX-1005: - Proportion of participants with incidence of the composite of death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, skin necrosis, limb gangrene, organ ischemia or infarction
- Time from study drug initiation to any incidence of the composite of death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, skin necrosis, limb gangrene, organ ischemia or infarction
- Time from the first dose of study drug to change to oral anticoagulant treatment
- Time from study drug initiation to each element of the composite as a separate endpoint: death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, skin necrosis, limb gangrene, organ ischemia or infarction - Proportion of participants with incidence of each element of the composite as a separate endpoint: death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, skin necrosis, limb gangrene, organ ischemia or infarction

To evaluate the time to onset of any
incidence of major bleeding following
treatment with VLX-1005:
-Time from study drug initiation to occurrence of any incidence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding

To evaluate the incidence of major bleeding following treatment with VLX-1005
-Proportion of participants with incidence of major bleeding as defined by ISTH criteria

To evaluate the pharmacokinetics (PK) of VLX-1005:
-Sparse PK sampling (10 samples) will be performed to inform a population PK model as further described in the PK Analysis Plan

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: - 99 Years
• Gender: All