NCT05727657

Satralizumab in Aneurysmal Subarachnoid Hemorrhage

A Phase 1 Clinical Trial of Satralizumab as a Treatment for Aneurysmal Subarachnoid Hemorrhage

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

In this study, satralizumab will be administered to see whether satralizumab is safe in patients with a burst brain aneurysm and if it may prevent strokes in patients with a burst brain aneurysm.

Detailed description

SASH is a prospective single-arm, single-center, open-label Phase 1 trial of satralizumab 120mg subcutaneous Day 0 and Day 14 in subjects with Hunt Hess grade 1-3, Fisher score 3 aneurysmal subarachnoid hemorrhage and an external ventricular drain or lumbar drain. The trial is designed to demonstrate safety and to detect a signal that satralizumab prevents delayed cerebral ischemia in these patients.

Conditions

• Aneurysmal Subarachnoid Hemorrhage
• Delayed Cerebral Ischemia

Interventions

Type	Name	Description
DRUG	Satralizumab	120mg subcutaneous Day 0 and Day 14

Timeline

• Start date: 2024-06-01
• Primary completion: 2024-06-24
• Completion: 2024-06-24
• First posted: 2023-02-14
• Last updated: 2025-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study