A Study to Learn More About How Well BAY3018250 Works and How Safe it is for People With Proximal Deep Vein Thrombosis (SIRIUS)
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| ClinicalTrials.gov Identifier: NCT06149520 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2023
Last Update Posted : May 10, 2024
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Researchers are looking for a better way to treat people who have deep vein thrombosis (DVT).
DVT is a condition that occurs when a blood clot forms in a deep vein in the leg. DVT is called 'proximal' when the clot is formed in the veins of the hip, thigh, and knee. DVT can cause serious health problems. The blood clots in the veins can break loose and can then travel through the bloodstream and get stuck in the lungs, blocking blood flow to the lungs. Symptoms of DVT include swelling, pain, and tenderness in the affected leg, as well as redness and warmth in the area. Currently, DVT is usually treated using blood thinners to prevent the clot from getting bigger or breaking off and traveling to the lungs. However, blood thinners may not be able to remove a blood clot quickly and may not be suitable for everyone who has DVT.
BAY3018250 is a drug that works by dissolving blood clots. In this study, researchers will compare BAY3018250 with placebo to learn how well it works and how safe it is in participants with proximal DVT. A placebo looks like the study drug but does not have any medicine in it. Using a placebo helps researchers to confirm that the results observed during the study were caused by the study drug and not by other factors.
The main purposes of this study are to learn:
- How well BAY3018250 works in dissolving blood clots in participants with proximal DVT and
- How safe is BAY3018250 as a treatment for participants with proximal DVT?
For this, the researchers will use ultrasound tests to measure blood clots in participants before and at various times after study treatment. They call these measurements a clot burden score. They will compare the clot burden score before and after treatment and will calculate a complex measure called AUC. This tells researchers how the clots have changed over time.
And researchers will collect the number of bleeding events that require medical attention.
The study participants will be randomly (by chance) assigned to one of 3 treatment groups. Dependent on the group, they will receive a single dose of high dose or low dose of BAY3018250 or placebo.
Researchers will closely monitor participants for 90 days after receiving the study treatment.
During the study, the doctors and their study team will:
- take blood samples
- do physical examinations
- examine heart health using electrocardiogram (ECG)
- check vital signs such as blood pressure, heart rate
- undergo ultrasound tests to measure the blood clots
- ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Thrombolysis Symptomatic Proximal Deep Vein Thrombosis | Drug: BAY3018250 Drug: Placebo to BAY3018250 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 3018250 in Patients With Symptomatic Proximal Deep Vein Thrombosis |
| Actual Study Start Date : | January 15, 2024 |
| Estimated Primary Completion Date : | May 2, 2025 |
| Estimated Study Completion Date : | July 3, 2025 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: BAY3018250 Dose 1
Participants will receive BAY3018250 Dose 1.
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Drug: BAY3018250
Dose 1 or dose 2 of BAY3018250 |
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Experimental: BAY3018250 Dose 2
Participants will receive BAY3018250 Dose 2.
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Drug: BAY3018250
Dose 1 or dose 2 of BAY3018250 |
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Placebo Comparator: Placebo to BAY3018250
Participants will receive placebo to BAY3018250.
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Drug: Placebo to BAY3018250
Matching placebo to BAY3018250 |
- AUCn(6h-30d) of the ratio to baseline of clot burden, as assessed by repeated quantitative ultrasound [ Time Frame: at 6 hours, 24 hours, Day 7, Day 30 ]Area under the curve (AUC) with respect to the measurement time points at 6 hours, 24 hours, 7 days and 30 days of the ratio to baseline of clot burden
- Number of participants with composite of major and clinically relevant non-major (CRNM) bleeding events (ISTH definition) [ Time Frame: up to Day 15 ]The classify of bleeding events use the International Society on Thrombosis and Haemostasis (ISTH) definitions.
- Ratio to baseline of clot burden, as assessed by quantitative ultrasound [ Time Frame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90 ]
- Change from baseline in leg pain severity [ Time Frame: at 6 hours, 24 hours, Day 7, Day 30 and Day 90 ]Likert pain scale is used as a quantitative measure of patient reported pain based on the participant´s judgement. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
- Change from baseline in PVFS scale [ Time Frame: at Day 7, Day 30 and Day 90 ]PVFS stands for post venous thromboembolism functional status. PVFS scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death), with higher scores being worse and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle.
- Number of participants with recurrent venous thromboembolism [ Time Frame: up to Day 90 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female (if postmenopausal or hysterectomized) aged 18 years or older
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Acute symptomatic proximal deep vein thrombosis (DVT) documented by compression ultrasound (CUS) and all of the following:
- duration of symptoms 14 days or less
- Proximal DVT involving at least 2 of the following proximal veins: the popliteal vein, the femoral vein, the common femoral vein and the external iliac vein
- adequate visualization of the most proximal end of the thrombus
- receiving therapeutic dose anticoagulation with low molecular weight heparins (LMWHs) and/or direct oral anticoagulants (DOACs) according to the respective product labels
- Measured body weight within 50 to 130 kg
- Signed informed consent
Exclusion Criteria:
- Acute symptomatic pulmonary embolism (PE)
- Active bleeding or high risk for bleeding (at the discretion of the investigator)
- Recent (<3 months) ischemic stroke, myocardial infarction, intracranial hemorrhage, or major surgery or severe trauma (at the discretion of the investigator)
- Active cancer, i.e., locally active, regionally invasive or metastatic and/or anticancer therapy within the last 6 months, except basal cell or squamous cell carcinoma
- Therapeutic-dose anticoagulants for > 72 hours before randomization, or current use of vitamin K antagonists
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Planned or current use of the following medications:
- Any antiplatelet therapy, except acetylsalicylic acid (ASA) ≤100 mg/day
- Antifibrinolytic drugs
- Male participants with women of childbearing potential (WOCBP) partners unwilling to use highly effective contraception from start of study intervention until end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06149520
| Contact: Bayer Clinical Trials Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT06149520 |
| Other Study ID Numbers: |
22138 2023-503315-15-00 ( Registry Identifier: CTIS (EU) ) |
| First Posted: | November 29, 2023 Key Record Dates |
| Last Update Posted: | May 10, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |