Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.

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

Details

• Lead Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: Aurum Biosciences Ltd; University of Glasgow

Criteria

Inclusion Criteria:

• Aged ≥18 years.

• Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.

• Ischaemic stroke <72h after onset.

• Previous functional independence (estimated mRS <3).

• Capacity to consent.

Exclusion Criteria:

• Women of child bearing potential.

• Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media).

• Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).

• Clinical need for, or contraindication to, supplemental oxygen.

• Known impaired renal function (eGFR <30ml/min) precluding radiological contrast.

• Known thrombocytopaenia (platelet count <150x109) or history of platelet function disorder.

• Known intercurrent infection.

• Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months).

• Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases >3 times upper limit of normal).

• Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days.

• Any medical condition potentially limiting survival within the study follow-up period.

• Participation in another CTIMP within preceding 90 days.