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Monoclonal Antibodies

Tocilizumab-aazg for Brain Aneurysm (THRIVE Trial)

Gainesville, FL

Phase 1

Waitlist Available

Led By Brian Hoh, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

Must have external ventricular drain or lumbar drain, or plan to place an external ventricular drain or lumbar drain

Adult patients (aged ≥18 years) with Hunt Hess Grade 1-3, Fisher score 3 or 3 and 4, aneurysmal subarachnoid hemorrhage within 24 hours of symptom onset (ruptured aneurysm confirmed by CTA, MRA or DSA)

Must not have

Evidence of active or untreated latent tuberculosis or interstitial lung disease

Poor peripheral venous access

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a drug called tocilizumab-aazg (TYENNE) is safe for patients with a burst brain aneurysm and if it can help prevent strokes

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Who is the study for?

This trial is for patients who've had a burst brain aneurysm, which can lead to subarachnoid hemorrhage and increase the risk of stroke and cognitive issues. Specific eligibility details are not provided, but typically participants must meet certain health standards.Check my eligibility

What is being tested?

The study tests tocilizumab-aazg (TYENNE), focusing on its safety in those with a recent burst brain aneurysm and its potential to prevent further strokes or cerebral ischemia following such an event.See study design

What are the potential side effects?

While specific side effects for TYENNE aren't listed here, similar medications may cause immune system suppression leading to infections, allergic reactions, infusion-related reactions, liver enzyme elevations, and blood count changes.

Eligibility Criteria

Inclusion Criteria

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

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I have or will have a drain placed in my head or spine.

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I am an adult with a mild to moderate brain hemorrhage from a ruptured aneurysm, diagnosed within the last day.

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I agree to not have unprotected sex or donate sperm.

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Exclusion Criteria

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

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I do not have active or untreated TB or lung disease.

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I have difficulty with blood draws or IV insertions due to poor vein access.

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I don't have any serious health issues that would stop me from safely completing the study.

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I have had a serious infection treated with antibiotics before screening.

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I have not had serious infections like pneumonia or sepsis before joining.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 90 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier for reporting.