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

Acute Ischaemic Stroke Clinical Trial

— POST-IT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03463551
• Other study ID #: GN16ST187
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2018
• Est. completion date: March 2020

Study information

• Verified date: August 2018
• Source: NHS Greater Glasgow and Clyde
• Contact: Maureen Travers
• Phone: +44 1412321813
• Email: Maureen.Travers[@]ggc.scot.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Only a small proportion of patients are currently suitable for treatment with "clot busting" drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more people to be treated. Currently available methods require extra time to acquire and are not therefore widely used. By carrying significant extra oxygen to the brain, the ABL-101 molecule may not only allow the visualisation of salvageable tissue, but also prevent progression of stroke damage in and have an additional direct benefit on tissue survival. Studies in animal models of stroke show smaller areas of stroke damage after ABL-101. There is therefore a rationale for testing this molecule in stroke patients, both as a diagnostic method, and also as a potential therapeutic agent.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: March 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischaemic Stroke
• Stroke

Intervention

Drug:
• ABL-101
ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.

Other:
• 0.9% NaCl
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	Aurum Biosciences Ltd, University of Glasgow

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.	Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).	7 days±2
Secondary	Mortality		30 days
Secondary	Incidence of serious adverse events throughout the entire study period.		30 days±5
Secondary	Incidence of adverse events of special interest		30 days±5
Secondary	Incidence of adverse reactions, adverse events, serious adverse events and serious adverse reactions, up to visit 7 (30±5 days) post administration of Investigational medicinal product.		30 days±5
Secondary	Modified Rankin Scale (mRS) distribution at day 30.	The mRS is a hierarchical ordinal scale used to assess disability in stroke trials, with seven discrete levels that range from No Symptoms (mRS=0) to death (mRS=6). The Rankin Focused Assessment tool will be used to derive day 30 mRS.	At day 30
Secondary	Follow-up infarct volume on MRI brain at visit 4.		48hrs (40-72hrs)