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

Description

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.

Conditions

Thrombocytopenia, Immune, Heparin Induced Thrombocytopenia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Thrombocytopenia, Immune
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

New Haven

Yale University, New Haven, Connecticut, United States, 06510

Washington

Georgetown University, Washington, District of Columbia, United States, 20007

Washington

MedStar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Durham

Duke University, Durham, North Carolina, United States, 27710

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Philadelphia

Universiy of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Veralox Therapeutics,

John Alexander, MD, STUDY_CHAIR, Duke Clinical Research Institute

Study Record Dates

2025-03-31