Veralox Study: VLX-1005 vs. Placebo in Participants With Suspected Heparin-Induced Thrombocytopenia
About
This is a randomized, double-blind, phase 2 pilot study of VLX-1005 vs. placebo in participants with suspected heparin-induced thrombocytopenia (HIT) treated with background standard of care.
In some people treated with heparin, an immune reaction can be triggered, causing antibodies to form. These antibodies can cause unwanted blood clots which can lead to strokes, heart attacks and damage to limbs and internal organs. This is called heparin-induced thrombocytopenia, also known as HIT.
This study will be testing a new experimental drug called VLX-1005 to see if it slows the progression or stops the development of HIT by halting the immune-system response that causes the blood clots. Up to 60 participants will be enrolled and randomized into two groups—a study medication group and a placebo group—and treated with the drug or placebo for seven to 14 days. After the last dose, participants will be asked to come in for a 30-day follow-up visit.
Eligibility Criteria
Inclusion Criteria
- Adult participants ≥18 years of age
- Able to provide informed consent or have informed consent provided on their behalf by a primary caregiver prior to study-related activities being initiated
- Recent unfractionated heparin or low-molecular-weight heparin exposure
- QPC <150 X 109/L and clinical 4T score of ≥4; candidate for argatroban or bivalirudin SoC treatment
- Positive PF4-immunoassay (e.g., ELISA [≥1.0 OD units], LIA [≥1.0 U/mL], CLIA [≥1.0 U/mL]).
Exclusion Criteria
- Treatment with argatroban or bivalirudin for >48 hr.
- Participants cannot receive other anti-coagulants, such as fondaparinux and danaparoid, or direct oral anti-coagulants, such as rivaroxaban, as initial standard of care.
- QTcF >450 msec for males or >470 msec for females
- History of hepatitis C antibody, hepatitis B surface antigen or human immunodeficiency virus (HIV) antibody at screening
- Current renal disease with a calculated creatinine clearance less than 30 mL/min.
- Participants with a history of substance abuse or dependency or history of recreational IV drug use (by self-declaration)
- Suspected history of alcohol abuse in the 6 months prior to screening
- 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
- Participants with cancer, having a life expectancy of <12 months
- Current diagnosis of, or any other clinically significant indication of, active sepsis
- Pregnant or lactating women (section 11.1.6.4; appendix C).
- Have participated in any other investigational drug trial within 30 days of dosing or five half-lives (whichever is longer) in the current study
Primary Investigator
Mark Joseph, M.D., is a cardiothoracic surgeon with over 15 years of clinical and research experience. He is an associate professor of surgery at the Virginia Tech Carilion School of Medicine. He is board certified by the American Board of Surgery in Critical Care and General Surgery, as well as by the American Board of Thoracic Surgery in Thoracic and Cardiac Surgery. He completed his fellowship, internship, and residency at the University of North Carolina Hospitals.
Contact Information
Angelica Flanders, B.S.
Clinical Research Coordinator
