A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Thrombocytopenia, Immune, Heparin Induced Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT05785819
- Run by
- Veralox Therapeutics
- People needed
- 24
- Starts
- 2023-09-26
- Expected to finish
- 2025-11-17
- Last updated by the study team
- 2025-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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]).
You may not qualify if…
- 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.
- Have participated in any other investigational drug trial within 30 days of dosing or 5 half-lives (whichever is longer) in the current study.
- In the opinion of the investigator, unlikely to comply with key elements of the protocol or otherwise inappropriate for the study.
Where it is running
- Stanford University — Stanford, California, United States
- University of Colorado — Aurora, Colorado, United States
- Yale University — New Haven, Connecticut, United States
- Georgetown University — Washington D.C., District of Columbia, United States
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Duke University — Durham, North Carolina, United States
- Oregon Health and Science University — Portland, Oregon, United States
- Universiy of Pennsylvania — Philadelphia, Pennsylvania, United States
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Carilion Medical Center — Roanoke, Virginia, United States
- University of Washington — Seattle, Washington, United States
- Versiti at Froedtert Hospital — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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