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Bay 3018250

This article explores the ongoing clinical trial of BAY 3018250, a promising new drug being studied for the treatment of proximal deep vein thrombosis (DVT). The trial aims to assess the effectiveness and safety of BAY 3018250 in patients with this condition, comparing it to standard treatments. We’ll discuss the study’s objectives, eligibility criteria, and potential implications for future DVT treatment.

Table of Contents

What is BAY 3018250?

BAY 3018250 is a new medication being developed by Bayer AG. It is currently undergoing clinical trials to evaluate its effectiveness and safety in treating certain blood clot conditions. The drug is administered as a concentrate for solution for infusion, which means it’s given directly into the bloodstream through a vein.[1]

What Medical Condition Does BAY 3018250 Treat?

BAY 3018250 is being studied for the treatment of proximal deep vein thrombosis (DVT). DVT is a serious condition where blood clots form in the deep veins, usually in the legs. “Proximal” refers to clots that occur in the upper part of the leg or thigh. These clots can be dangerous because they can break loose and travel to the lungs, causing a potentially life-threatening condition called pulmonary embolism.[1]

How Does BAY 3018250 Work?

While the exact mechanism of action is not fully described in the provided information, BAY 3018250 appears to be designed to help with clot lysis. This means it may help to break down or dissolve blood clots. The study aims to quantify the effect of BAY 3018250 on clot lysis in patients with proximal DVT.[1]

Current Clinical Trial Information

A clinical trial is currently underway to study BAY 3018250. This trial is described as a randomized, double-blind, placebo-controlled, multi-center study. Let’s break down what this means:

  • Randomized: Participants are randomly assigned to different treatment groups.
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual drug and who is receiving a placebo.
  • Placebo-controlled: Some participants will receive a placebo (a substance with no active ingredients) instead of the actual drug.
  • Multi-center: The study is being conducted at multiple hospitals or research centers.

This type of study design helps ensure that the results are as unbiased and reliable as possible.[1]

Who Can Participate in the Study?

The study has specific criteria for who can participate. Here are some key points:

  • Participants must be 18 years or older
  • Both males and females can participate (females must be postmenopausal or have had a hysterectomy)
  • Participants must have acute symptomatic proximal deep vein thrombosis (DVT) confirmed by ultrasound
  • Symptoms must have been present for 14 days or less
  • The DVT must involve at least one of the following veins: popliteal, femoral, common femoral, or external iliac vein
  • Participants must weigh between 50 to 130 kg

There are also several conditions that would prevent someone from participating, such as:

  • Having a pulmonary embolism (blood clot in the lung) that requires specific treatments
  • Active bleeding or high risk of bleeding
  • Recent stroke, heart attack, brain bleeding, or major surgery
  • Active cancer
  • Use of certain medications

These criteria help ensure the safety of participants and the reliability of the study results.[1]

How is the Study Designed?

The study is designed to test different doses of BAY 3018250 against a placebo. Participants will be divided into three groups:

  1. BAY 3018250 Dose 1 group
  2. BAY 3018250 Dose 2 group
  3. Placebo group

Each participant will receive a single dose of their assigned treatment. The study will last for 90 days, including one overnight stay in the hospital after receiving the treatment. Throughout the study, participants will undergo various tests and assessments to monitor the effects of the treatment.[1]

How Will the Effectiveness of BAY 3018250 be Measured?

The study will use several methods to measure how well BAY 3018250 works:

  • Clot burden assessment: Researchers will use ultrasound to measure the size of the blood clot over time (at 6 hours, 24 hours, 7 days, 30 days, and 90 days after treatment).
  • Pain assessment: Participants will rate their leg pain severity at various time points.
  • Functional status: The study will assess how well participants can function after the treatment.
  • Recurrence of blood clots: The number of participants who experience new blood clots will be tracked.

These measurements will help determine if BAY 3018250 is effective at dissolving blood clots and improving symptoms associated with DVT.[1]

Safety Considerations

An important part of this study is to assess the safety of BAY 3018250. The researchers will be closely monitoring for any side effects, particularly bleeding events. They will track the number of participants who experience major or clinically relevant non-major bleeding up to 15 days after receiving the treatment.

It’s important to note that while this drug shows promise, it is still in the testing phase. More research is needed to fully understand its effectiveness and safety profile. Patients should always consult with their healthcare providers about the most appropriate treatments for their specific condition.[1]

Aspect Details
Drug Name BAY 3018250
Condition Studied Proximal Deep Vein Thrombosis (DVT)
Study Type Randomized, double-blind, placebo-controlled, multi-center study
Primary Objectives 1. Quantify effect on clot lysis
2. Assess safety
Key Eligibility Criteria 1. Age 18 or older
2. Acute symptomatic proximal DVT
3. Symptoms for 14 days or less
4. Weight between 50 to 130 kg
Main Outcome Measures 1. Change in clot burden over time
2. Occurrence of bleeding events
Study Duration 90 days per participant

FAQ

  • What is BAY 3018250 and what is it being studied for? BAY 3018250 is a new drug being investigated for the treatment of proximal deep vein thrombosis (DVT). It's being studied to see how well it can break down blood clots and how safe it is for patients with this condition.
  • Who can participate in this clinical trial? The trial is open to men and women aged 18 or older with acute symptomatic proximal DVT. Participants must have symptoms for 14 days or less, meet specific vein involvement criteria, and be receiving anticoagulation therapy. There are also weight requirements and other eligibility factors.
  • How is the effectiveness of BAY 3018250 being measured? The main way of measuring effectiveness is by looking at the change in clot size over time. This is done using repeated ultrasound scans at 6 hours, 24 hours, 7 days, and 30 days after treatment. The study also looks at changes in leg pain and overall function after DVT.
  • What are the safety considerations in this trial? Safety is a key focus of the trial. The researchers are particularly looking at the occurrence of major and clinically relevant non-major bleeding events up to 15 days after treatment. Patients with a high risk of bleeding or recent major health events are not eligible to participate.
  • How long does the trial last for each participant? The trial follows participants for a 90-day period after they receive the study treatment. This includes one overnight stay in the hospital after the drug is administered, followed by several follow-up visits over the next three months.

Ongoing Clinical Trials on Bay 3018250

  • A study testing the safety and effects of BAY 3018250 given as a single infusion in increasing doses in healthy men compared to placebo

    Not recruiting

    1
    Investigated drugs:
    Germany

  • Study on the Effectiveness and Safety of BAY 3018250 and Low Molecular Weight Heparin for Patients with Proximal Deep Vein Thrombosis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia France Germany Greece +5

Glossary

  • Proximal Deep Vein Thrombosis (DVT): A blood clot that forms in the large veins of the upper leg or pelvis.
  • Thrombolysis: The process of breaking down blood clots.
  • Anticoagulation: Treatment that helps prevent blood clots from forming or growing larger.
  • Compression Ultrasound (CUS): A medical imaging technique used to diagnose deep vein thrombosis by applying pressure with the ultrasound probe to see if the vein collapses.
  • Low Molecular Weight Heparins (LMWHs): A type of blood thinner used to treat and prevent blood clots.
  • Direct Oral Anticoagulants (DOACs): Newer blood-thinning medications taken by mouth to prevent or treat blood clots.
  • Pulmonary Embolism (PE): A blockage in one of the pulmonary arteries in your lungs, often caused by blood clots that travel from the legs or other parts of the body.
  • Randomized, Double-blind, Placebo-controlled Study: A type of clinical trial where participants are randomly assigned to different treatment groups, neither the participants nor the researchers know who is receiving the actual treatment, and a placebo is used for comparison.
  • Clot Burden: The amount or size of a blood clot in a blood vessel.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-bay-3018250-and-low-molecular-weight-heparin-for-patients-with-proximal-deep-vein-thrombosis/