Overview

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.