SFX-01 After Subarachnoid Haemorrhage

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SFX-01 in Subarachnoid Haemorrhage, with exploratory evaluations of efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Evgen Pharma

Criteria

Inclusion Criteria:

1. Patients with radiological evidence of spontaneous SAH

2. Fisher grade 3 or 4 on CT

3. Definitive treatment of aneurysm has not been ruled out

4. Previously living independently

5. In the opinion of the investigator, the delay from ictus to randomisation and initiation of trial medication will not exceed 48 hours

6. Aged 18 to 80 years

7. In the opinion of the investigator it will be possible to obtain Informed Consent from the Patient, Personal Legal Representative or Professional Legal representative within 24 hours of first dose

Exclusion Criteria:

1. Traumatic SAH

2. Fisher grade 1 or 2

3. SAH diagnosed on lumbar puncture with no evidence of blood on CT

4. Decision not to treat aneurysm has been made

5. Plan to withdraw treatment

6. Significant kidney disease as defined as plasma creatinine ≥2.5mg/dL (221 µmol/l)

7. Liver disease as defined as total bilirubin ≥2-fold the upper limit of normal; (ULN) as measured by the local laboratory

8. Females who are pregnant or lactating.

9. Participants enrolled in another interventional research trial in the last 30 days

10. Patients for whom it is known, at the time of screening, that clinical follow-up will not be feasible Patients unwilling to use two forms of contraception (one of which being a barrier method) 30 days for men and 90 days for women after last IMP dose