What side effects are associated with this type of intervention?

Common treatments for Deep Vein Thrombosis (DVT) include low-molecular-weight heparins (e.g., dalteparin), direct oral anticoagulants (DOACs) such as rivaroxaban and apixaban, and vitamin K antagonists like warfarin. The primary side effect of these anticoagulants is an increased risk of bleeding, which can range from minor bruising to severe hemorrhage. Other side effects may include gastrointestinal issues, liver enzyme elevation, and, in the case of heparins, potential for heparin-induced thrombocytopenia (HIT). For Factor XI inhibitors like Abelacimab, the side effect profile is still being studied, but bleeding risk remains a primary concern.

What prior FDA approvals exist?

The FDA has approved several anticoagulants for the treatment of Deep Vein Thrombosis (DVT). These include direct oral anticoagulants (DOACs) such as dabigatran, rivaroxaban, apixaban, and edoxaban, which inhibit thrombin or Factor Xa. Low-molecular-weight heparins (LMWH) like enoxaparin have also been approved. While Factor XI inhibitors like Abelacimab are currently under study, they represent a novel approach to anticoagulation by targeting a different part of the coagulation cascade compared to traditional therapies.

What other types of research exist?

Promising novel alternatives to Abelacimab for DVT patients include: 1) Concizumab, an anti-TFPI antibody, which has shown efficacy in hemophilia and is being investigated for broader anticoagulation use. 2) Mim8, a bispecific antibody that mimics Factor VIIIa, showing potential in severe vascular challenges. 3) Recombinant fusion proteins like rIX-FP and N9-GP, which offer extended half-lives and improved pharmacokinetics for better management of coagulation disorders.

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Monoclonal Antibodies

Abelacimab vs Dalteparin for Blood Clot Prevention in Cancer Patients (MAGNOLIA Trial)

Phase 3

Recruiting

Research Sponsored by Anthos Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Anticoagulation therapy with LMWH for at least 6 months is indicated

Confirmed GI or GU cancers if unresectable, locally advanced, metastatic, or non-metastatic and no intended curative surgery during the study

Must not have

History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for dalteparin

PE leading to hemodynamic instability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares a new medication, Abelacimab, to another treatment, Dalteparin, in patients with GI or GU cancer who have had blood clots. The goal is to see which treatment better prevents new clots and reduces bleeding risks.

Who is the study for?

This trial is for adults with gastrointestinal or genitourinary cancer who have had a recent deep vein thrombosis or pulmonary embolism. They must be able to take blood thinners for at least 6 months and not have any planned major surgery, brain trauma, severe liver issues, uncontrolled high blood pressure, or a life expectancy under 3 months.

What is being tested?

The study compares Abelacimab to Dalteparin in preventing blood clot recurrence and managing bleeding risks in patients with certain cancers. It's an open-label trial where the effects of each treatment are evaluated by researchers unaware of which group participants belong to.

What are the potential side effects?

Potential side effects may include bleeding complications, allergic reactions to medication components, possible liver enzyme elevations, and other organ-specific inflammation due to the anticoagulant nature of both Abelacimab and Dalteparin.

Eligibility Criteria

Inclusion Criteria

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

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I have been on blood thinner medication for at least 6 months.

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My GI or GU cancer cannot be surgically removed, is advanced, or has spread.

Exclusion Criteria

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

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I am allergic to the study drug or similar medications.

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I have had a blood clot in my lung that affected my heart's ability to pump blood.

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I have been on blood thinners for more than 5 days.

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My blood pressure is not controlled even with medication.

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I have had bleeding that needed medical attention in the last 4 weeks.

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I am not scheduled for any major surgery in the next 4 weeks.

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I have brain cancer or untreated cancer spread to the brain.

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I have severe health problems and spend most of my time in bed or a chair.

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I am a woman who can have children and will not or cannot use effective birth control during the study.

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I agree to use reliable contraception if I am sexually active.

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I do not have severe liver issues or significantly high liver enzyme levels.

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

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I have had a procedure or treatment for a blood clot.

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I do not have an ongoing heart infection.

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I take more than 100 mg/day of aspirin or another drug to prevent blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AbelacimabExperimental Treatment1 Intervention

Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Group II: DalteparinActive Control1 Intervention

Dalteparin administered subcutaneously daily

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Deep Vein Thrombosis (DVT) include anticoagulants such as Factor XI inhibitors (e.g., Abelacimab), direct oral anticoagulants (DOACs) like rivaroxaban and apixaban, and low-molecular-weight heparin (LMWH). Factor XI inhibitors work by targeting and inhibiting Factor XI in the coagulation cascade, which reduces the formation of blood clots with potentially lower bleeding risks. DOACs inhibit Factor Xa or thrombin, preventing clot formation. LMWH enhances the activity of antithrombin, which inactivates thrombin and Factor Xa. These treatments are crucial for DVT patients as they prevent clot propagation and recurrence, reducing the risk of complications such as pulmonary embolism and post-thrombotic syndrome.

Anticoagulation in the obese patient with COVID-19-associated venous thromboembolism.Treatment of upper extremity deep vein thrombosis with apixaban and rivaroxaban.Factor XI inhibition fulfilling the optimal expectations for ideal anticoagulation.