VLX-1005 for Heparin Induced Thrombocytopenia

Phase 2

Recruiting

Research Sponsored by Veralox Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult participants ≥ 18 years of age

Be older than 18 years old

Must not have

Current renal disease with a calculated creatinine clearance less than 30 mL/min

Participants with cancer, having a life expectancy of < 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to14 days

Summary

This trial will evaluate a drug to treat heparin induced thrombocytopenia (HIT), looking at platelet count, stroke, pulmonary embolism & bleeding.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions related to immune system changes due to inhibition of the enzyme targeted by VLX-1005. Common issues could involve bleeding risks or clotting problems given that it's being tested in patients with blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My doctor expects I have less than 12 months to live due to my cancer.

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I do not have an active infection or sepsis.

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I am not taking certain blood thinners like fondaparinux, danaparoid, or rivaroxaban.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to recovery of platelet count to ≥ 150 X 10^9/L in patients with a positive serotonin release assay

Secondary study objectives

Composite of death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, skin necrosis, limb gangrene, organ ischemia or infarction

Incidence of death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, organ ischemia or infarction

Proportion of participants with any element of the composite as a separate endpoint: death, amputation, new thrombosis, stroke, systemic embolism, myocardial infarction, deep vein thrombosis or pulmonary embolism, organ ischemia or infarction

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