Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05363397
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2022-05-02
Brief Title:
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STARS
Brief Summary:
STARS is a prospective multicentre open-label dose escalation Phase IIa study to assess the safety and tolerability of TBO-309 an adjuvant antiplatelet therapy in patients with AIS
Acute ischaemic stroke AIS is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage However even after successful treatment re-blockage of arteries can occur The use of an antiplatelet therapy TBO-309 in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage
Acute ischaemic stroke AIS is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage However even after successful treatment re-blockage of arteries can occur The use of an antiplatelet therapy TBO-309 in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage
Detailed Description:
Stroke is a leading cause of disability worldwide with most strokes in Australia being Acute ischaemic stroke AIS AIS is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain Timely restoration of blood flow is critical to preserve brain function Standard therapies target the blocked artery by either dissolving the blockage intravenous thrombolysis IVT or removing the blockage endovascular thrombectomy EVT However even after successful treatment re-blockage of arteries can occur The use of an antiplatelet therapy in addition to IVTEVT offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage
STARS is a prospective multicentre open-label dose escalation Phase IIa study to assess the safety and tolerability of TBO-309 an adjuvant antiplatelet therapy in patients with AIS The study will test the hypothesis that AIS patients who are treated with TBO-309 in conjunction with standard therapy IVT alone or IVT EVT will not experience higher rates of ICH compared to the expected rates of ICH in patients treated with only standard therapy IVT alone or IVT EVT
TBO-309 is a potent selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesionaggregation and promotes platelet disaggregation thereby specifically inhibiting thrombosis without interfering with normal haemostasis In order to evaluate safety at lower doses four dose levels in total will be administered using a serial dose-escalation design Doses will be assigned based on a dose escalation methodology commencing with lower doses assigned early in the study As safety criteria are satisfied based on ICH rates doses will be increased The dosage strength of TBO-309 to be administered 30mg 60mg 120mg or 180mg will be assigned by the study database
Patients presenting to hospital with an AIS will be assessed according to the trial inclusion and exclusion criteria by the Principal Investigator or nominated delegate on admission to the Emergency Department Consent will be sought from either the patient or their Person ResponsibleMedical Treatment Decision Maker prior to enrolment into the study Standard therapy either IVT alone or IVT EVT will commence and the TBO-309 will be administered at the same time as standard therapy Following administration of study drug and treatment with standard therapies patients will receive usual supportive care either in the Intensive Care Unit or in the hospital ward Any significant neurological deterioration will require an emergency non-contrast CT head to assess for the presence of ICH All patients will receive a 24-36 hour MRI or a multimodal CT to assess asymptomatic bleeding recanalisation and infarct volume
During the patients hospital stay clinical outcome data will be collected during the study period to document response to treatment and to monitor safety Study patients will be followed-up for 90 days post-enrolment or to death whichever is the earlier
STARS is a prospective multicentre open-label dose escalation Phase IIa study to assess the safety and tolerability of TBO-309 an adjuvant antiplatelet therapy in patients with AIS The study will test the hypothesis that AIS patients who are treated with TBO-309 in conjunction with standard therapy IVT alone or IVT EVT will not experience higher rates of ICH compared to the expected rates of ICH in patients treated with only standard therapy IVT alone or IVT EVT
TBO-309 is a potent selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesionaggregation and promotes platelet disaggregation thereby specifically inhibiting thrombosis without interfering with normal haemostasis In order to evaluate safety at lower doses four dose levels in total will be administered using a serial dose-escalation design Doses will be assigned based on a dose escalation methodology commencing with lower doses assigned early in the study As safety criteria are satisfied based on ICH rates doses will be increased The dosage strength of TBO-309 to be administered 30mg 60mg 120mg or 180mg will be assigned by the study database
Patients presenting to hospital with an AIS will be assessed according to the trial inclusion and exclusion criteria by the Principal Investigator or nominated delegate on admission to the Emergency Department Consent will be sought from either the patient or their Person ResponsibleMedical Treatment Decision Maker prior to enrolment into the study Standard therapy either IVT alone or IVT EVT will commence and the TBO-309 will be administered at the same time as standard therapy Following administration of study drug and treatment with standard therapies patients will receive usual supportive care either in the Intensive Care Unit or in the hospital ward Any significant neurological deterioration will require an emergency non-contrast CT head to assess for the presence of ICH All patients will receive a 24-36 hour MRI or a multimodal CT to assess asymptomatic bleeding recanalisation and infarct volume
During the patients hospital stay clinical outcome data will be collected during the study period to document response to treatment and to monitor safety Study patients will be followed-up for 90 days post-enrolment or to death whichever is the earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1270-5195 | OTHER | World Health Organization WHO Universal Trial Number UTN | None |