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

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]).

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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. 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 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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