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

Primary Purpose

Acute Ischaemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABL-101
0.9% NaCl
Sponsored by
NHS Greater Glasgow and Clyde
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischaemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    ABL-101 IV as per dosing cohort + Supplementary O2 for 24h

    IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Mortality
    Incidence of serious adverse events throughout the entire study period.
    Incidence of adverse events of special interest
    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.
    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.
    Follow-up infarct volume on MRI brain at visit 4.

    Full Information

    First Posted
    March 6, 2018
    Last Updated
    August 1, 2018
    Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow, Aurum Biosciences Ltd
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03463551
    Brief Title
    Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic
    Acronym
    POST-IT
    Official Title
    Perfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2018 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    March 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NHS Greater Glasgow and Clyde
    Collaborators
    University of Glasgow, Aurum Biosciences Ltd

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Ischaemic Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    18 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ABL-101 IV as per dosing cohort + Supplementary O2 for 24h
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    IV 0.9% NaCl as per dosing cohort + supplementary O2 for 24h
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    ABL-101
    Intervention Description
    ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.
    Intervention Type
    Other
    Intervention Name(s)
    0.9% NaCl
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
    Description
    Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).
    Time Frame
    7 days±2
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    30 days
    Title
    Incidence of serious adverse events throughout the entire study period.
    Time Frame
    30 days±5
    Title
    Incidence of adverse events of special interest
    Time Frame
    30 days±5
    Title
    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
    Title
    Modified Rankin Scale (mRS) distribution at day 30.
    Description
    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.
    Time Frame
    At day 30
    Title
    Follow-up infarct volume on MRI brain at visit 4.
    Time Frame
    48hrs (40-72hrs)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maureen Travers
    Phone
    +44 1412321813
    Email
    Maureen.Travers@ggc.scot.nhs.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alicia Murray
    Email
    Alicia.Murray@glasgow.ac.uk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keith Muir
    Organizational Affiliation
    University of Glasgow
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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