VLX-1005 for Heparin Induced Thrombocytopenia

No longer recruiting at 15 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment called VLX-1005 for people with heparin-induced thrombocytopenia (HIT), a condition where certain blood thinners cause a drop in platelet count, increasing the risk of dangerous blood clots. Participants will receive either VLX-1005 or a placebo (a harmless substance) alongside their usual care to assess its impact on platelet counts and the risk of clotting or bleeding events, such as strokes or clots in the lungs. Individuals who have recently been exposed to heparin and experienced a significant drop in platelet levels might be suitable candidates. As a Phase 2 trial, this research focuses on evaluating VLX-1005's effectiveness in an initial, smaller group, offering a chance to contribute to important medical advancements.

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.

Is there any evidence suggesting that VLX-1005 is likely to be safe for humans?

Research has shown that VLX-1005 is safe and well-tolerated in past studies. An earlier study with healthy participants reported no serious side effects. Participants took VLX-1005 without experiencing major negative reactions.

Although this earlier study involved healthy individuals, it provides some confidence about the safety of VLX-1005. The current study is in its second phase, indicating that initial testing has shown the treatment is generally safe for humans. However, further testing is needed to confirm its safety in people with heparin-induced thrombocytopenia, a condition where a blood thinner causes low platelet counts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIT?

Most treatments for Heparin-Induced Thrombocytopenia (HIT) work by inhibiting thrombin generation with anticoagulants like argatroban or bivalirudin. However, VLX-1005 stands out because it targets the immune response that triggers HIT, potentially offering a more direct approach to preventing platelet destruction. Researchers are excited about VLX-1005 because of its novel mechanism of action, which could provide a more effective and safer option for patients by addressing the root cause of the condition rather than just managing symptoms.

What evidence suggests that VLX-1005 might be an effective treatment for heparin induced thrombocytopenia?

In this trial, participants will receive either VLX-1005 or a placebo. Previous studies have shown that VLX-1005 holds promise for treating heparin-induced thrombocytopenia (HIT), a condition where blood clots form unexpectedly. Research indicates that VLX-1005 blocks an enzyme involved in clot formation. Initial findings suggest that VLX-1005 may reduce the risk of complications like stroke and clots in the lungs. Researchers are also evaluating the treatment's ability to help platelets recover. These results offer hope that VLX-1005 could effectively manage HIT symptoms and complications. ^{1 2 4 6 7}

Who Is on the Research Team?

John Alexander, MD

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. yalemedicine.org yalemedicine.org/clinical-trials/vlx-1005-versus-placebo-in-participants-with-suspected-heparin-induced-thrombocytopenia

A Phase 2 Study of VLX-1005 Versus Placebo in ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05785819

NCT05785819 | A Phase 2 Study of VLX-1005 Versus ... The study will measure important outcomes including platelet count recovery time, stroke, pulmonary embolus, deep vein thrombosis, myocardial infarction, limb ...

3. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/vlx-1005-versus-placebo-in-participants-with-suspected-heparin-induced-thrombocytopenia/

A Phase 2 Study of VLX-1005 Versus Placebo in Suspected ... The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding. Ages. 18 years ...

4. ahajournals.org ahajournals.org/doi/10.1161/atvb.42.suppl_1.132

Abstract 132: VLX-1005 Effectively Treats Heparin-induced ... The studies presented here demonstrate the potential effectiveness of VLX-1005 in intervention of platelet activation, clot formation, and thrombosis.

5. mayo.edu mayo.edu/research/clinical-trials/cls-20556749

A Phase 2 Study of VLX-1005 Versus Placebo in ... The study will measure important outcomes including platelet count, stroke, pulmonary embolus (clot to the lungs) and bleeding. Participation ...

6. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/2614/530154/Phase-1-3-Sequence-Interaction-Study-of

Phase 1, 3-Sequence Interaction Study of Intravenous Vlx ... All treatment regimens appeared to be safe and well tolerated by the male and female healthy human subjects in this study; no evidence of ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124053679

Phase 1, 3-Sequence Interaction Study of Intravenous Vlx ... The coadministration of VLX-1005 with argatroban had no impact on the effect of argatroban on aPTT in healthy human adult subjects. The Phase 2 ...