A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia (NCT05785819) | Clinical Trial Compass
TerminatedPhase 2
A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia
Stopped: Veralox Therapeutics Business Decision.
United States24 participantsStarted 2023-09-26
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of VLX-1005, a 12-lipoxygenase (12-LOX) enzyme inhibitor in treating heparin induced thrombocytopenia (HIT). Participants with suspected HIT will receive the usual standard of care, and will be assigned randomly to either VLX-1005 or placebo treatment. The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Adult participants ≥ 18 years of age.
✓. Able to provide informed consent or have informed consent provided on their behalf by a primary caregiver prior to study-related activities being initiated.
✓. Recent unfractionated heparin or low-molecular-weight heparin exposure.
✓. Qualifying platelet count \< 150 X 10\^9/L and clinical 4T score of ≥ 4; candidate for argatroban or bivalirudin treatment.
✓. Positive PF4-immunoassay (eg, ELISA \[≥ 1.0 optical density units\], LIA \[≥ 1.0 U/mL\], CLIA \[≥ 1.0 U/mL\]).
Exclusion criteria
✕. Treatment with argatroban or bivalirudin for ≥ 60 hrs prior to randomization.
✕. Following discontinuation of heparin, participants cannot be treated with a non-heparin anti-coagulant for ≥ 60 hours.
✕. Current renal dialysis.
✕. Pregnant or lactating women.
What they're measuring
1
Time to recovery of platelet count to ≥ 150 X 10^9/L in patients with a positive serotonin release assay