Experimental drug aims to restore platelets in Heparin-Triggered disorder
NCT ID NCT05785819
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested an experimental drug called VLX-1005 in people with a rare condition where the blood thinner heparin causes a dangerous drop in platelets (cells that help blood clot). Participants received either VLX-1005 or a placebo alongside standard care. The goal was to see if the drug could help platelet levels recover faster and prevent complications like blood clots or stroke. The study was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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24 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Carilion Medical Center
Roanoke, Virginia, 24014, United States
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Duke University
Durham, North Carolina, 27710, United States
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Georgetown University
Washington D.C., District of Columbia, 20007, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Stanford University
Stanford, California, 94305, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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University of Colorado
Aurora, Colorado, 80045, United States
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University of Michigan
Ann Arbor, Michigan, 48109, United States
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University of Washington
Seattle, Washington, 98195, United States
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Universiy of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Versiti at Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
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Yale University
New Haven, Connecticut, 06510, United States
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