VLX-1005 for Heparin Induced Thrombocytopenia

Recruiting at 13 trial locations

Overseen By Christopher Cavallaro, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Veralox Therapeutics

Must be taking: Heparin

Must not be taking: Argatroban, Bivalirudin

Disqualifiers: Renal dialysis, Pregnant, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have been treated with argatroban or bivalirudin for 60 hours before joining. Also, you cannot use a non-heparin anti-coagulant for 60 hours after stopping heparin.

Research Team

John Alexander, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

Adults over 18 with suspected heparin induced thrombocytopenia (HIT) can join this trial. They must have had recent heparin exposure, a specific blood test result indicating HIT, and a low platelet count. People with hepatitis B/C, HIV, severe kidney disease, substance abuse history or those unlikely to follow the study plan are excluded.

Inclusion Criteria

I have recently been treated with heparin.

You have a positive blood test for PF4, which may indicate a specific medical condition.

Able to provide informed consent or have informed consent provided on their behalf by a primary caregiver prior to study-related activities being initiated

Exclusion Criteria

I have been treated with argatroban or bivalirudin for more than 48 hours before being assigned to a treatment group.

Your heart's QT interval is longer than 450 milliseconds if you're male, or longer than 470 milliseconds if you're female.

My kidney function is low, with a creatinine clearance under 30 mL/min.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either VLX-1005 or placebo intravenously every 12 hours for 7 to 14 days, alongside standard anticoagulation therapy

1-2 weeks

Daily visits (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including platelet count recovery and incidence of major bleeding

2 weeks

Treatment Details

Interventions

• Placebo
• VLX-1005

Trial Overview The trial is testing VLX-1005 against a placebo in patients who might have HIT. Participants will also receive standard care for HIT and be randomly assigned to either the drug or placebo group. The main focus is on whether VLX-1005 improves platelet counts and reduces complications like stroke or lung clots.

Participant Groups

Group I: VLX-1005 Experimental Treatment 1 Intervention

VLX-1005 200 mg given every 12 hours by intravenous infusion over 1 hour.

Group II: Placebo Placebo Group 1 Intervention

Placebo given every 12 hours by intravenous infusion over 1 hour.

VLX-1005 is already approved in European Union, United States for the following indications:

Approved in European Union as VLX-1005 for:

• Heparin-induced thrombocytopenia (HIT)

Approved in United States as VLX-1005 for:

• Heparin-induced thrombocytopenia (HIT)

Who Is Running the Clinical Trial?

Veralox Therapeutics

Lead Sponsor

Trials

3

Recruited

170+