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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• Qualifying platelet count \< 150 X 10\^9/L and clinical 4T score of ≥ 4; candidate for argatroban or bivalirudin treatment.
• Positive PF4-immunoassay (eg, ELISA \[≥ 1.0 optical density units\], LIA \[≥ 1.0 U/mL\], CLIA \[≥ 1.0 U/mL\]).
• \-
Locations
United States
California
Stanford University
RECRUITING
Stanford
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale University
RECRUITING
New Haven
Washington, D.c.
Georgetown University
RECRUITING
Washington D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Michigan
University of Michigan
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Duke University
RECRUITING
Durham
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Universiy of Pennsylvania
NOT_YET_RECRUITING
Philadelphia
Virginia
Carilion Medical Center
RECRUITING
Roanoke
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
Versiti at Froedtert Hospital
RECRUITING
Milwaukee
Contact Information
Primary
Michael S Hanna, MD
mhanna@veralox.com
301-360-3502
Backup
Christopher Cavallaro, MS
ccavallaro@veralox.com
301-360-3502
Time Frame
Start Date:2023-09-26
Estimated Completion Date:2025-03-31
Participants
Target number of participants:60
Treatments
Experimental: VLX-1005
VLX-1005 200 mg given every 12 hours by intravenous infusion over 1 hour.
Placebo_comparator: Placebo
Placebo given every 12 hours by intravenous infusion over 1 hour.