Evaluating VLX-1005 for treating suspected heparin induced thrombocytopenia

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

This study is testing a new treatment called VLX-1005 to see if it can help people with suspected heparin induced thrombocytopenia feel better and avoid serious complications.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Veralox Therapeutics (Industry-sponsored)
• Locations: 14 sites (Stanford, California and 13 other locations)
• Trial ID: NCT05785819 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of VLX-1005, an enzyme inhibitor, in patients with suspected heparin induced thrombocytopenia (HIT). Participants will receive standard care and be randomly assigned to either VLX-1005 or a placebo. The study will monitor key outcomes such as platelet count, incidence of stroke, pulmonary embolism, and bleeding events. The goal is to find a safer and more effective treatment option for HIT, which currently has high morbidity and mortality rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recent heparin exposure and a qualifying platelet count indicating suspected HIT.

Not a fit: Patients currently on anticoagulants like argatroban or bivalirudin for more than 60 hours prior to randomization may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce complications and improve outcomes for patients suffering from heparin induced thrombocytopenia.

How similar studies have performed: While the approach of using VLX-1005 is novel, previous studies have indicated the need for more effective treatments for HIT, highlighting a significant gap in current therapies.

Eligibility 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 \[≥ 1.0 optical density units\], LIA \[≥ 1.0 U/mL\], CLIA \[≥ 1.0 U/mL\]).

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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.

Where this trial is running

Stanford, California and 13 other locations

• Stanford University — Stanford, California, United States (Recruiting)
• University of Colorado — Aurora, Colorado, United States (Recruiting)
• Yale University — New Haven, Connecticut, United States (Recruiting)
• Georgetown University — Washington, District of Columbia, United States (Recruiting)
• MedStar Washington Hospital Center — Washington, District of Columbia, United States (Recruiting)
• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
• Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
• Universiy of Pennsylvania — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
• Carilion Medical Center — Roanoke, Virginia, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)
• Versiti at Froedtert Hospital — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Michael S Hanna, MD

Conditions Thrombocytopenia, Immune; Heparin Induced Thrombocytopenia; Heparin; Thrombocytopenia; Platelets