Infliximab for Aneurysms

Recruiting in Palo Alto (17 mi)

Overseen byDaniel L Cooke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Patients harboring dolichoectactic vertebrobasilar (DVB) aneurysms are at risk of suffering SAH, ischemic stroke, and/or brainstem compression and many patients are not offered invasive treatment due to the futility of existing surgical methods. Consequently, there is demand for development of medical therapy for DVB aneurysms

Eligibility Criteria

This trial is for adults over 18 with a specific type of aneurysm in the brain's arteries that can't be treated with surgery or other common methods. Participants must not have severe kidney issues, recent drug abuse, certain infections like HIV or TB, or liver problems. Women who could get pregnant must use effective contraception and not be breastfeeding.

Inclusion Criteria

I have a complex aneurysm in my brain that cannot be treated with surgery or through the blood vessels.

I am over 18 years old.

Exclusion Criteria

I have not had serious infections or needed strong antibiotics in the last month.

Any medical condition, which, in the opinion of the investigator, would put the subject at risk by participation in the protocol

I have a positive TB test but haven't completed or am not undergoing treatment for latent TB.

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Treatment Details

Interventions

Infliximab (Monoclonal Antibodies)

Trial OverviewThe trial tests Infliximab therapy on patients with dolichoectactic vertebrobasilar aneurysms to prevent stroke and brainstem compression. It seeks alternatives to surgical treatments which are often not viable for these patients.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Infliximab treatmentExperimental Treatment1 Intervention

Administer infliximab intravenously to patients with DVB aneurysms (3 mg/kg at 0, 3 and 7 weeks, then at 8-week intervals x 7) for a total of 12-months. Patients will undergo MR imaging at 0, 12, and 24-month time points.

Infliximab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Remicade for: