A Randomized, Double-Blind Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veralox Therapeutics
• Treatments: Enzyme Inhibitors

Criteria

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 OD units], LIA [≥ 1.0 U/mL], CLIA [≥ 1.0 U/mL]).

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Exclusion Criteria:

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. 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 sepsis

11. 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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