BAY3018250 for Blood Clots

Overseen By Bayer Clinical Trials Contact

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Bayer

Disqualifiers: Bleeding disorders, Thrombosis, Easy bruising, others

Compensation: Varies

Number of Visits: 8

Duration: 1 week

39 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers are looking for a better way to treat people who have acute venous and arterial thrombotic and thromboembolic events. These are severe medical problems due to blood clots forming in and blocking blood vessels. The study treatment BAY3018250 is under development to treat acute venous and arterial thrombotic and thromboembolic events. It aims to work by dissolving blood clots in the blood vessels. In this study, participants will be healthy and will not benefit from receiving BAY3018250. However, the study will provide information on how to test BAY3018250 in future studies in people with acute venous and arterial thrombotic and thromboembolic events. During the study, researchers will use two different methods of giving BAY3018250 to participants. This may help in developing a faster method of giving this treatment in case of emergencies. The main purpose of this study is to check how safe BAY3018250 is and if it is well tolerated by participants. For this, researchers will study the number and severity of medical problems in: * healthy Japanese men after receiving different doses of BAY3018250 as an infusion into a vein. * healthy adult participants after receiving a certain dose of BAY3018250 by an injection. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatment. This study will have two parts: Part A and Part B: - Only healthy Japanese men can join Part A of the study, which will have two groups. In the first group, participants will receive a low dose of BAY3018250. If researchers consider this dose to be safe, the next group will receive a higher dose. In each group, participants will be randomly assigned to receive BAY3018250 or placebo as an infusion into a vein once during the study. A placebo looks like a study drug but does not have any medicine in it. - Healthy men and women can join Part B of the study. Participants will be randomly assigned to receive a certain dose of BAY3018250 or placebo by an injection once during the study. Each participant will be in the study for around 14 weeks, which includes: * a visit to the hospital within 3 weeks of taking any treatment to confirm if the participant can take part in the study * a hospital stay of 1 week, during which participants will receive their assigned treatment, have blood and urine tests and complete health check-ups * six follow-up visits to the hospital until about 11 weeks after receiving the study treatments During the study, the doctors and their study team will check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) As this study is conducted in healthy participants who will not benefit from the treatment, access to the treatment after the study is not planned.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any medications that could affect your health status or the study results. Please consult with the study team for specific guidance.

What data supports the idea that BAY3018250 for Blood Clots is an effective treatment?

The available research does not provide specific data on BAY3018250 for treating blood clots. Instead, it discusses other treatments like fondaparinux and CY 222, which have shown effectiveness in reducing blood clots. For example, fondaparinux was found to be effective in major orthopedic surgery, and CY 222 showed improvement in 93% of patients with deep venous thrombosis. However, there is no direct information on BAY3018250's effectiveness for blood clots in the provided research. ^{1 2 3 4 5}

What safety data exists for BAY3018250 for blood clots?

The provided research does not mention BAY3018250 or its variants directly. The studies focus on the safety profiles of apixaban and rivaroxaban, which are anticoagulants used for preventing blood clots. These studies indicate that apixaban may have a lower risk of bleeding events compared to rivaroxaban in certain surgical contexts, and rivaroxaban has a similar safety profile to standard care in major orthopedic surgeries. However, there is no specific safety data for BAY3018250 in the provided research. ^{6 7 8 9 10}

Is BAY3018250 a promising drug for blood clots?

The information provided does not mention BAY3018250, so we cannot determine if it is a promising drug for blood clots based on the given research articles. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for healthy Japanese men, and other adults aged 18 to 55 who are overtly healthy as determined by medical evaluation. Participants must have a stable diet consistent with their Japanese heritage, not lived outside Japan for more than 10 years, and women must be postmenopausal or hysterectomized.

Inclusion Criteria

I am male.

I am Japanese, born in Japan, with Japanese ancestry, and have lived mostly in Japan without changing my diet significantly.

I am generally healthy as confirmed by a recent medical check-up.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of BAY3018250 or placebo via infusion or injection, with blood and urine tests and health check-ups

1 week

1 week hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including six follow-up visits

11 weeks

6 visits (in-person)

Treatment Details

Interventions

• BAY3018250

Trial Overview The study tests BAY3018250's safety and how it behaves in the body when given as an infusion or injection. It's aimed at treating blood clots but participants won't benefit directly; they'll receive either the drug or a placebo randomly during one hospital stay followed by several check-ups.

Participant Groups

Group I: Dose step 2 (Part B) Experimental Treatment 1 Intervention

Participants will receive a single dose of BAY3018250 dose step 2 via injection in part B.

Group II: Dose step 2 (Part A) Experimental Treatment 1 Intervention

Participants will receive a single dose of BAY3018250 dose step 2 via infusion in part A.

Group III: Dose step 1 (Part A) Experimental Treatment 1 Intervention

Participants will receive a single dose of BAY3018250 dose step 1 via infusion in part A.

Group IV: Placebo (Part A) Placebo Group 1 Intervention

Participants will receive a single dose of BAY3018250 matching placebo via infusion in part A.

Group V: Placebo (Part B) Placebo Group 1 Intervention

Participants will receive a single dose of BAY3018250 matching placebo via injection in part B.

Who Is Running the Clinical Trial?

Bayer

Lead Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Findings from Research

In a study of 125 patients with chronic immune thrombocytopenia, treatment with romiplostim significantly reduced bleeding-related episodes (BREs) by 56% compared to placebo, highlighting its efficacy in preventing bleeding in patients with severe thrombocytopenia.

The new composite endpoint for assessing BREs, which includes both actual bleeding events and the use of rescue medications, proved to be a valuable tool for understanding treatment effects and may improve future clinical trial assessments of bleeding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach to the evaluation of bleeding-related episodes in patients with chronic immune thrombocytopenia. Weitz, I., Sanz, MA., Henry, D., et al.[2016]

Fondaparinux, a selective factor Xa inhibitor, has been shown to significantly reduce thrombotic events in patients undergoing major orthopedic surgery, based on a comprehensive evaluation involving over 7000 participants across four phase III trials.

Its superior efficacy is likely due to its mechanism of selectively inhibiting factor Xa and its predictable pharmacokinetics, making it a promising option for preventing venous thromboembolism in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing prophylaxis of venous thromboembolism. Turpie, AG.[2018]

Abelacimab has been shown to be effective in preventing venous thromboembolism, as demonstrated in a clinical study, although specific details about the number of participants and study duration are not provided in the abstract.

The study suggests that abelacimab may offer a new therapeutic option for patients at risk of venous thromboembolism, potentially improving safety and efficacy compared to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-TKA abelacimab reduced VTE at 8 to 12 d compared with enoxaparin. Dunn, AS.[2022]

Surgical thrombectomy was performed on 17 out of 18 patients with severe acute DVT, leading to significant improvements in limb edema and arterial pulsation, with a 94.1% follow-up rate over an average of 34 months.

Despite one patient dying post-surgery, the majority experienced relief from symptoms, indicating that surgical thrombectomy is an effective treatment for severe acute DVT, although there were some cases of recurrence and complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of severe acute deep venous thrombosis in lower extremity]. Gu, YQ., Zhang, J., Qi, LX., et al.[2019]

In a phase-2 trial involving 30 patients with confirmed deep venous thrombosis, treatment with the low molecular weight heparin fragment CY 222 resulted in a significant reduction of clinical symptoms in 93% of patients.

Phlebographic assessments showed that 37% of patients experienced more than 75% lysis of the thrombus, indicating that CY 222 is effective in promoting vascular clearing, although 6.6% of patients had worsened thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of deep venous thrombosis with a very low molecular weight heparin fragment (CY 222). Janvier, G., Winnock, S., Dugrais, G., et al.[2018]

Low molecular weight heparins (LMWH) like enoxaparin and fondaparinux are effective and cost-efficient in preventing venous thromboembolism (VTE) in surgical patients.

Oral anticoagulants such as dabigatran and rivaroxaban are also approved in the EU for preventing VTE in adults undergoing elective hip or knee replacement surgeries, providing additional options for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticoagulation with {blacktriangledown}dabigatran or{blacktriangledown}rivaroxaban. [2015]

In a study involving 17,701 patients across 252 centers, rivaroxaban was found to significantly reduce the incidence of symptomatic thromboembolic events compared to standard thromboprophylaxis, demonstrating its superior efficacy in preventing blood clots after hip or knee surgery.

The safety profile of rivaroxaban was similar to that of standard care, with comparable rates of major bleeding events, confirming its favorable benefit-risk profile in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. Turpie, AG., Haas, S., Kreutz, R., et al.[2015]

In a meta-analysis of 12 clinical trials involving 12,195 patients, apixaban was found to significantly reduce the risk of major bleeding events (RR 0.56) and total bleeding events (RR 0.81) compared to enoxaparin in patients undergoing knee arthroplasty.

No significant differences in bleeding events were observed between rivaroxaban and enoxaparin for knee arthroplasty, and both drugs showed similar safety profiles in hip arthroplasty, indicating that apixaban may be a safer option for knee surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apixaban and rivaroxaban safety after hip and knee arthroplasty: a meta-analysis. Alves, C., Batel-Marques, F., Macedo, AF.[2015]

Apixaban is effective for treating venous thromboembolism (VTE) in cancer patients, demonstrating significant efficacy in reducing the risk of recurrent blood clots.

The study highlights the safety of apixaban, showing a favorable bleeding risk profile compared to traditional anticoagulants, making it a suitable option for cancer patients at risk of VTE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding. Riaz, IB., Marshall, AL., Badgett, RG.[2020]

This study is the first to analyze real-life data on the use of rivaroxaban in 16 pediatric cancer patients aged 7.5-17 years, focusing on its safety and efficacy for treating thrombosis.

While the thrombus resolution rate was similar to previous studies, our findings revealed higher rates of thrombotic and bleeding complications, particularly in patients with relapsed or refractory cancer, indicating a need for careful monitoring in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban treatment among children with cancer-associated thromboembolism: Real-world data. Barg, AA., Levy-Mendelovich, S., Gilad, O., et al.[2022]

The patient, diagnosed with polycythemia vera, initially managed with phlebotomy, later developed thrombocytosis and experienced serious complications including thromboses in the portal and superior mesenteric veins.

Intravenous anticoagulation therapy significantly improved her symptoms and liver function, leading to ongoing outpatient management with anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Superior mesenteric and portal vein thrombosis in a polycythemia vera patient with JAK2 mutation]. Araki, N., Takimoto, R., Chiba, H., et al.[2012]

Antithrombotic medications are commonly used in cancer patients for conditions like venous thromboembolism and stroke prevention, but managing these therapies during thrombocytopenia (low platelet count) poses significant challenges due to the risk of bleeding.

Recent findings suggest that aspirin may be safe for use in thrombocytopenic patients experiencing acute myocardial infarction, and that withholding anticoagulation in patients undergoing autologous stem cell transplantation carries a low risk of recurrent venous thromboembolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antithrombotic medication in cancer-associated thrombocytopenia: Current evidence and knowledge gaps. Leader, A., Ten Cate, H., Spectre, G., et al.[2019]

In myeloproliferative disorders like polycythaemia vera and essential thrombocythaemia, elevated haematocrit is a well-known risk factor for thrombosis, while thrombocytosis has not been definitively linked to increased thrombotic risk in essential thrombocythaemia.

Recent studies indicate that treatments such as hydroxyurea and aspirin are effective in managing these conditions, highlighting their therapeutic value in reducing thrombotic and bleeding risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thrombosis and haemorrhage in polycythaemia vera and essential thrombocythaemia. Elliott, MA., Tefferi, A.[2013]

In a study of 24 pediatric liver transplant recipients, intensive anticoagulant therapy was successfully implemented, and none of the patients developed hepatic artery thrombosis, a serious complication often seen in this population.

The therapy included a combination of low-molecular-weight heparin and other agents to maintain normal antithrombin III levels, suggesting that early correction of coagulation imbalances may be an effective strategy for preventing thrombosis in children after liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of hepatic artery thrombosis in pediatric liver transplantation. Hashikura, Y., Kawasaki, S., Okumura, N., et al.[2019]

Two young patients with chronic Budd-Chiari syndrome were successfully treated with mesocaval shunts and are doing well post-surgery, indicating that this surgical intervention can be effective for managing this condition.

The first case highlights a unique combination of risk factors, including the use of oral contraceptives, polycythaemia rubra vera, and high anti-cardiolipin antibodies, contributing to hypercoagulability in Budd-Chiari syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral contraceptives and blood diseases are the most common causes of Budd-Chiari syndrome]. Almer, S., Bodemar, G., Rydén, BO., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

A novel approach to the evaluation of bleeding-related episodes in patients with chronic immune thrombocytopenia. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Optimizing prophylaxis of venous thromboembolism. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Post-TKA abelacimab reduced VTE at 8 to 12 d compared with enoxaparin. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Treatment of severe acute deep venous thrombosis in lower extremity]. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of deep venous thrombosis with a very low molecular weight heparin fragment (CY 222). [2018]

6. England pubmed.ncbi.nlm.nih.gov

Anticoagulation with {blacktriangledown}dabigatran or{blacktriangledown}rivaroxaban. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Apixaban and rivaroxaban safety after hip and knee arthroplasty: a meta-analysis. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

In cancer-associated VTE, apixaban was noninferior to dalteparin for recurrence and did not increase major bleeding. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Rivaroxaban treatment among children with cancer-associated thromboembolism: Real-world data. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Superior mesenteric and portal vein thrombosis in a polycythemia vera patient with JAK2 mutation]. [2012]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Antithrombotic medication in cancer-associated thrombocytopenia: Current evidence and knowledge gaps. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Thrombosis and haemorrhage in polycythaemia vera and essential thrombocythaemia. [2013]

14. United States pubmed.ncbi.nlm.nih.gov

Prevention of hepatic artery thrombosis in pediatric liver transplantation. [2019]

15. Sweden pubmed.ncbi.nlm.nih.gov

[Oral contraceptives and blood diseases are the most common causes of Budd-Chiari syndrome]. [2016]