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

Overview

About this study

The purpose of this study is to evaluate the effiectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion 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]).

Exclusion Criteria:

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 01/03/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Damon Houghton, M.D., M.S.

Open for enrollment

Contact information:

Preventive Heart Research Team

(507) 538-7425

RSTCRVRUPREVENT@mayo.edu

More information

Publications

Publications are currently not available