A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia

Trial ID or NCT#

NCT05785819

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Randomized, Double-Blind, Phase 2 Pilot Study of VLX-1005 Versus Placebo in Participants With Suspected Heparin Induced Thrombocytopenia Treated With Background Standard of Care

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Adult participants ≥ 18 years of age.2. Able to provide informed consent or have informed consent provided on their behalf by a primary caregiver prior to study-related activities being initiated.3. Recent unfractionated heparin or low-molecular-weight heparin exposure.4. Qualifying platelet count \< 150 X 10\^9/L and clinical 4T score of ≥ 4; candidate for argatroban or bivalirudin treatment.5. Positive PF4-immunoassay (eg, ELISA \[≥ 1.0 optical density units\], LIA \[≥ 1.0 U/mL\], CLIA \[≥ 1.0 U/mL\]).
    1. -
Exclusion Criteria:
  1. 1. Treatment with argatroban or bivalirudin for ≥ 60 hrs prior to randomization.2. Following discontinuation of heparin, participants cannot be treated with a non-heparin anti-coagulant for ≥ 60 hours.3. Current renal dialysis.4. Pregnant or lactating women.5. Have participated in any other investigational drug trial within 30 days of dosing or 5 half-lives (whichever is longer) in the current study.6. In the opinion of the investigator, unlikely to comply with key elements of the protocol or otherwise inappropriate for the study.
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Investigator(s)

Robert Diep, MD
Hematologist
Clinical Assistant Professor, Medicine - Hematology
William James Collins
William James Collins
Clinical Assistant Professor, Medicine
Nidhi Rohatgi, MD MS
Nidhi Rohatgi, MD MS
Hospitalist
Clinical Professor, Medicine Clinical Professor (By courtesy), Neurosurgery Clinical Professor (By courtesy), Anesthesiology, Perioperative and Pain Medicine

View on ClinicalTrials.gov