Tolerability of the perfluorocarbon oxygen carrier ABL-101 in patients with acute ischaemic stroke
- Conditions
- Acute ischaemic strokeMedDRA version: 20.0 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-003232-36-GB
- Lead Sponsor
- HS Greater Glasgow & Clyde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 18
•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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.;<br> Secondary Objective: To investigate the GOLD imaging technique in patients with acute stroke.<br> To provide data on sample size and event rates to inform the design of a phase 2b randomised, controlled trial with clinical end-points.<br> ;Primary end point(s): Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).;Timepoint(s) of evaluation of this end point: Visit 6 (7±2)
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): 1. Mortality<br> 2. Incidence of serious adverse events<br> 3. Incidence of AEs of special interest<br> 4. Incidence of ARs, AEs, SAEs, and SARs<br> 5. Modified Rankin Scale (mRS)<br> 6. Follow-up infarct volume on MRI brain<br> ;<br> Timepoint(s) of evaluation of this end point: Secondary endpoints 1 -3 will be evaluated throughout the entire study period.<br><br> The incidence of ARs, AEs, SAEs, and SARs will be collected up to visit 7 (30 ± 5 days) post administration of IMP.<br><br> Modified Rankin Scale (mRS) distribution at day 30<br><br> Follow-up infarct volume on MRI brain will be assessed at visit 4 at 48 hours (40-72 hours)<br>