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Enzyme Inhibitor

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to14 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

+4 more

Side effects data

From 2011 Phase 3 trial • 2201 Patients • NCT00004562

14%

Death from all causes

NYHA class III or IV Heart Failure

Nonfatal reinfarction

100%

80%

60%

40%

20%

Study treatment Arm

Percutaneous Coronary Intervention Group

Medical Therapy Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VLX-1005Experimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VLX-1005

2022

Completed Phase 1

~110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Veralox TherapeuticsLead Sponsor

2 Previous Clinical Trials

108 Total Patients Enrolled

John Alexander, MDStudy ChairDuke Clinical Research Institute

4 Previous Clinical Trials

5,065 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the federal government sanctioned VLX-1005 for general use?

"Although there is some evidence of VLX-1005's safety, its efficacy has yet to be confirmed. Therefore, we have conservatively estimated a score of 2 for this drug in Phase 2 trials."

Answered by AI

How many individuals are receiving enrollment into this clinical trial?

"Affirmative. According to the facts provided on clinicaltrials.gov, this research is actively seeking participants that fit its criteria; first posted on September 26th 2023 and edited thereafter on the 27th of the same month. 60 patients are needed across a single medical centre."

Answered by AI

Are there any vacancies for this clinical research project?

"As per clinicaltrials.gov, this medical trial has been released and is actively searching for participants. The study was introduced on September 26th 2023 with the most recent edit occuring a day later, on September 27th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Phase 2 Study of VLX-1005 Versus Placebo in Suspected Heparin Induced Thrombocytopenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05785819.

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