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

Trial ID or NCT#

NCT05785819

Status

not recruiting iconNOT RECRUITING

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 \[≥ 1.0 U/mL\]).
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Exclusion Criteria:
  1. 1. Previous treatment with argatroban or bivalirudin for \> 48 hr prior to randomization.2. Participants cannot receive other anti-coagulants, such as fondaparinux and danaparoid, or direct oral anti-coagulants, such as rivaroxaban as initial standard of care.3. QT interval corrected by the method of Fridericia (QTcF) \> 450 msec for males, \> 470 msec for females.4. History of hepatitis C antibody, hepatitis B surface antigen, or human immunodeficiency virus (HIV) antibody at screening.5. Current renal disease with a calculated creatinine clearance less than 30 mL/min.6. Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration).7. Participant has a suspected history of alcohol abuse in the 6 months prior to screening.8. Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.9. Participants with cancer, having a life expectancy of \< 12 months.10. Current diagnosis of or any other clinically significant indication of active sepsis11. Pregnant or lactating women.12. Have participated in any other investigational drug trial within 30 days of dosing or 5 half-lives (whichever is longer) in the current study.
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Investigator(s)

Nidhi Rohatgi, MD MS
Nidhi Rohatgi, MD MS
Hospitalist
Clinical Professor, Medicine Clinical Professor (By courtesy), Neurosurgery

View on ClinicalTrials.gov