Acute Ischaemic StrokePhase 2POST-ITNCT03463551
Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic
A Phase 2 study testing ABL-101 and 0.9% NaCl in people with Acute Ischaemic Stroke, run by NHS Greater Glasgow and Clyde.
Trial summary
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischaemic Stroke
- What is being tested?
- ABL-101 and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
Alicia Murray contact
About this study
Official title: Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Read the detailed 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.
- Conditions
- Acute Ischaemic Stroke
- Being tested
- ABL-101, 0.9% NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL-101Drug
ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.
0.9% NaClOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| ABL-101 IV as per dosing cohort + Supplementary O2 for 24h | Experimental | Patients will receive either ABL-101 or placebo (equivalent volume of 0.9% Sodium Chloride) within ascending dose groups of 6 patients each (4 to ABL-101, 2 to placebo).The starting cohort will be Cohort 1: 0.5mL/kg.
In the event that the start dose of Cohort 1 is considered intolerable in the opinion of the iDMC based on incidence of patients experiencing dose-limiting toxicities (DLTs), the iDMC will have the option of recommending a lower dose cohort (Cohort -1) of 0.25ml/kg (to a maximum of 25ml) be undertaken.
Cohort 1: 0.5 mL/kg to a maximum of 50ml; Cohort 2: 1.5mL/kg to a maximum of 150ml; Cohort 3: 3.0mL/kg to a maximum of 300ml.
All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration. Receives: Drug: ABL-101 |
| IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h | Placebo comparator | Cohort 1: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 2: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 3: Volume matched to the calculation used for ABL-101 using patient weight.
All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration. Receives: Other: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 days±2
Secondary outcomes (6)
Mortality
Measured: 30 days
Incidence of serious adverse events throughout the entire study period.
Measured: 30 days±5
Incidence of adverse events of special interest
Measured: 30 days±5
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.
Measured: 30 days±5
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.
Measured: At day 30
Follow-up infarct volume on MRI brain at visit 4.
Measured: 48hrs (40-72hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Aurum Biosciences Ltd
- Responsible party
- Sponsor
- Investigators
- Keith Muir, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463551
- Sponsor's protocol ID
- GN16ST187
- Acronym
- POST-IT
- Status last verified
- Aug 2018
- First submitted
- 6 Mar 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)
- ClinicalTrials.gov ID
- NCT03463551
- Acronym / sponsor ID
- POST-IT / GN16ST187
- Conditions
- Acute Ischaemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Aurum Biosciences Ltd
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABL-101 IV as per dosing cohort + Supplementary O2 for 24h | Experimental | Drug: ABL-101Patients will receive either ABL-101 or placebo (equivalent volume of 0.9% Sodium Chloride) within ascending dose groups of 6 patients each (4 to ABL-101, 2 to placebo).The starting cohort will be Cohort 1: 0.5mL/kg. In the event that the start dose of Cohort 1 is considered intolerable in the opinion of the iDMC based on incidence of patients experiencing dose-limiting toxicities (DLTs), the iDMC will have the option of recommending a lower dose cohort (Cohort -1) of 0.25ml/kg (to a maximum of 25ml) be undertaken. Cohort 1: 0.5 mL/kg to a maximum of 50ml; Cohort 2: 1.5mL/kg to a maximum of 150ml; Cohort 3: 3.0mL/kg to a maximum of 300ml. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration. |
| IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h | Placebo comparator | Other: 0.9% NaClCohort 1: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 2: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 3: Volume matched to the calculation used for ABL-101 using patient weight. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABL-101ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration. | Drug | ABL-101 IV as per dosing cohort + Supplementary O2 for 24h |
| 0.9% NaClPlacebo | Other | IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h |
Primary outcome
To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Time frame: 7 days±2
Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).
6 secondary outcomes
Mortality
Time frame: 30 days
Incidence of serious adverse events throughout the entire study period.
Time frame: 30 days±5
Incidence of adverse events of special interest
Time frame: 30 days±5
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.
Time frame: 30 days±5
Modified Rankin Scale (mRS) distribution at day 30.
Time frame: At day 30
Follow-up infarct volume on MRI brain at visit 4.
Time frame: 48hrs (40-72hrs)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Murray contact
Keith Muir principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABL-101 and 0.9% NaCl in people with Acute Ischaemic Stroke, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maureen Travers (+44 1412321813, Maureen.Travers@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients. (time frame: 7 days±2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.