TERMINATED

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

Conditions

Thrombocytopenia, Immune Heparin Induced Thrombocytopenia Heparin Thrombocytopenia Platelets

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of VLX-1005, a 12-lipoxygenase (12-LOX) enzyme inhibitor in treating heparin induced thrombocytopenia (HIT). Participants with suspected HIT will receive the usual standard of care, and will be assigned randomly to either VLX-1005 or placebo treatment. The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding.

Official Title

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

Quick Facts

Study Start:2023-09-26

Study Completion:2025-11-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05785819

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 \[≥ 1.0 U/mL\]).	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.

Inclusion Criteria

Exclusion 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 \[≥ 1.0 U/mL\]).

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.

Contacts and Locations

Principal Investigator

John Alexander, MD

STUDY_CHAIR

Duke Clinical Research Institute

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

University of Colorado

Aurora, Colorado, 80045

United States

Yale University

New Haven, Connecticut, 06510

United States

Georgetown University

Washington D.C., District of Columbia, 20007

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Duke University

Durham, North Carolina, 27710

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Universiy of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Carilion Medical Center

Roanoke, Virginia, 24014

United States

University of Washington

Seattle, Washington, 98195

United States

Versiti at Froedtert Hospital

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Veralox Therapeutics

John Alexander, MD, STUDY_CHAIR, Duke Clinical Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-26

Study Completion Date2025-11-17

Study Record Updates

Study Start Date2023-09-26

Study Completion Date2025-11-17

Terms related to this study

Keywords Provided by Researchers

Heparin
Thrombocytopenia
Platelets

Additional Relevant MeSH Terms

Thrombocytopenia, Immune
Heparin Induced Thrombocytopenia