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Experimental drug aims to restore platelets in Heparin-Triggered disorder

NCT ID NCT05785819

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

24 people

The number who actually took part.

Started

Sep 2023

Finished

Nov 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Carilion Medical Center

    Roanoke, Virginia, 24014, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Georgetown University

    Washington D.C., District of Columbia, 20007, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Stanford University

    Stanford, California, 94305, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Universiy of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Versiti at Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Yale University

    New Haven, Connecticut, 06510, United States

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