https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385922&isReview=true&fbclid=IwAR2yCbbpq0kmlPYbWspyTVCgX8WTChPcM1oYrdiM4QIjhB6NdLuXrotT4Bk_aem_AeDIHFOOnG9AxQEAvwvNhSGQnwGLvTqS_J3xibRsd8oqp1mTwHDUWzZWjadBMbG0ORngyQLOjqh7sZnO_-ebIVfFTrial registered on ANZCTRRegistration numberACTRN12623001110673Ethics application statusApprovedDate submitted24/09/2023Date registered25/10/2023Date last updated4/04/2024Date data sharing statement initially provided25/10/2023Type of registrationProspectively registeredTitles & IDsPublic titleA Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke PatientsScientific titleA Phase II, Multicenter, Double-Blinded, Randomized, Placebo-Controlled, Parallel-Group, Single-Dose Study to Determine the Safety, Preliminary Efficacy, and Pharmacokinetics of ARG-007 in Acute Ischemic Stroke PatientsSecondary ID [1]NilUniversal Trial Number (UTN)Trial acronymSEANCONLinked study recordHealth conditionHealth condition(s) or problem(s) studied:StrokeAcuteCondition categoryCondition codeStrokeIschaemicIntervention/exposureStudy typeInterventionalDescription of intervention(s) / exposureTreatment: Drugs - ARG-007
Experimental: ARG-007 - Single intravenous infusion of ARG-007 0.3 mg/kg over 10 minutes, administered in hospital by registered nurse. Participants are to be administered the ARG-007 as soon after randomization as possible but before the completion of endovascular revascularization (using mechanical thrombectomy with or without thrombolysis).
Participants will be followed up in hospital on Day 2, Day 3, Day 6 (or Discharge), Safety assessments including vital signs, NIHSS and laboratory will be carried out during these visits. Additionally, an NCCT will be performed at day 2 and an MRI at day 3.
Following discharge participants will be followed up by telephone on Day 30, and Day 90 (End of Study [EoS]). Questionnaires will be collected during these visits to assess safety & efficacy.Intervention code [1]Treatment: DrugsComparator / control treatmentSaline Placebo
There are no differences in procedures, activities, and/or processes between the intervention and placebo group.Control groupPlaceboOutcomesPrimary outcome [1]To evaluate the safety of a single dose of ARG-007 in participants with acute ischemic stroke (AIS).
The primary analyses will be mortality rate and frequency of AEs/SAEs.
Site personnel will collect AE information from participants. Open-ended
and nonleading questions will be used to enquire about any AEs/SAEs.Timepoint [1]Day 1, Day 2, Day 3, Day 6 or Discharge, Day 30 and Day 90 (Primary timepoint).Secondary outcome [1]The efficacy analysis is the difference in infarct volume between the ARG-007 and placebo groups as measured by MRI (or NCCT if MRI is not available) at 48 hours (Day 3 ± 1 day).Timepoint [1]Day 3 post-intervention.EligibilityKey inclusion criteria1) Diagnosis of AIS deemed suitable for endovascular revascularization (mechanical thrombectomy with or without a thrombolytic agent).
2) Aged >/= 18 years.
3) Stroke onset (last known well) time < /= 24 hours before randomization.
4) The National Institutes of Health Stroke Scale (NIHSS) >/= 5 points at time of randomization.
5) Pre-stroke modified Rankin Score (mRS) < /= 3. Participant must have been living in their own home, apartment, or a senior’s lodge where no nursing care is required.
6) Confirmed symptomatic intracranial occlusion, based on computed tomographic angiography (CTA), at one or more of the following locations: intracranial internal carotid artery (T/L morphology) or M1 middle cerebral artery.
7) For participants transferring to stroke center from another hospital, CTA for study eligibility is to be performed or repeated at stroke center with endovascular suite onsite if there is a long delay (> 6 hours) from time of first CTA to time of repeat CTA.
8) Signed informed consent from participant or their legally authorized representative, or if required to enable inclusion by applicable national laws and regulations and the applicable Institutional Review Board/Ethics Committee requirements for obtaining consent from the investigator after consultation with an independent physician who is not otherwise participating in the study.
9) Willing (participant and/or caretaker) to commit to follow up assessments.Minimum age18 YearsMaximum ageNo limitSexBoth males and femalesCan healthy volunteers participate?NoKey exclusion criteria1) Evidence of a large core of established infarction defined as ASPECTS of 0 to 5.
2) Evidence of intracranial hemorrhage or mass lesion on the qualifying imaging.
3) Endovascular revascularization procedure has already been completed at the time of Screening/randomization or has been completed before administration of study drug.
4) Planned use of an endovascular device that is not approved or does not have clearance by the relevant regulatory authority.
5) Rapid spontaneous improvement of neurological signs during Screening, as defined by a reduction of >/= 8 on the NIHSS between onset of symptoms and randomization.
6) History of stroke (ischemic or hemorrhagic) or penetrating head injury within 90 days before enrollment.
7) Uncontrolled blood pressure (BP) >/= 180/110 mmHg before endovascular revascularization procedure is initiated.
8) No femoral pulses, very difficult endovascular access, or extreme tortuosity of the great vessels that is predicted to result in an inability to timely deliver endovascular therapy. Direct common carotid or radial/brachial/axillary access is permissible.
9) Estimated or known body weight < 45 kg or > 130 kg.
10) Pregnancy: If a woman is of childbearing potential and has a positive point-of-care urine beta-human chorionic gonadotropin (ß-HCG) test or is breastfeeding.
11) Severe known renal impairment defined as requiring dialysis (hemo- or peritoneal) or a creatinine clearance < 29 mL/min.
12) Severe or fatal comorbid illness that will prevent improvement or follow-up.
13) Cannot complete follow-up visits because participant is a visitor to the area, or any other known reason that would prevent attendance at follow-up visits.
14) Received treatment with an investigational drug or device within 30 days before enrollment.
15) Any other condition that, in the opinion of the investigator, may adversely affect the safety of the participant, the participant’s ability to complete the study, or the outcome of the study.Study designPurpose of the studyTreatmentAllocation to interventionRandomised controlled trialProcedure for enrolling a subject and allocating the treatment (allocation concealment procedures)Methods used to generate the sequence in which subjects will be randomised (sequence generation)Masking / blindingBlinded (masking used)Who is / are masked / blinded?The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/dataIntervention assignmentParallelOther design featuresPhasePhase 2Type of endpoint/sSafety/efficacyStatistical methods / analysisRecruitmentRecruitment statusRecruitingDate of first participant enrolmentAnticipated13/03/2024Actual28/03/2024Date of last participant enrolmentAnticipated31/10/2025ActualDate of last data collectionAnticipated30/01/2026ActualSample sizeTarget92Accrual to date3FinalRecruitment in AustraliaRecruitment state(s)NSW,QLD,SA,WA,VICRecruitment hospital [1]The Royal Adelaide Hospital - AdelaideRecruitment hospital [2]Princess Alexandra Hospital - WoolloongabbaRecruitment hospital [3]Monash Medical Centre - Clayton campus - ClaytonRecruitment hospital [4]Fiona Stanley Hospital - MurdochRecruitment hospital [5]Sir Charles Gairdner Hospital - NedlandsRecruitment hospital [6]John Hunter Hospital - New LambtonRecruitment hospital [7]Liverpool Hospital - LiverpoolRecruitment hospital [8]Royal Melbourne Hospital - Royal Park campus - ParkvilleRecruitment hospital [9]Royal Brisbane & Womens Hospital - HerstonRecruitment hospital [10]Gold Coast University Hospital - SouthportRecruitment postcode(s) [1]5000 - AdelaideRecruitment postcode(s) [2]4102 - WoolloongabbaRecruitment postcode(s) [3]3168 - ClaytonRecruitment postcode(s) [4]6150 - MurdochRecruitment postcode(s) [5]6009 - NedlandsRecruitment postcode(s) [6]2305 - New LambtonRecruitment postcode(s) [7]2170 - LiverpoolRecruitment postcode(s) [8]3050 - Royal Melbourne HospitalRecruitment postcode(s) [9]4029 - HerstonRecruitment postcode(s) [10]4215 - SouthportFunding & SponsorsFunding source category [1]Commercial sector/IndustryName [1]Argenica Therapeutics LtdCountry [1]AustraliaPrimary sponsor typeCommercial sector/IndustryNameArgenica Therapeutics LtdCountryAustraliaSecondary sponsor category [1]NoneName [1]Country [1]Ethics approvalEthics application statusApprovedEthics committee name [1]St. Vincent’s Hospital (Melbourne) Human Research Ethics CommitteeEthics committee address [1]41 Victoria Parade, Fitzroy, VIC 3065Ethics committee country [1]AustraliaDate submitted for ethics approval [1]18/07/2023Approval date [1]11/09/2023Ethics approval number [1]SummaryBrief summaryThe primary purpose of this single dose study is to assess the safety and preliminary efficacy of ARG-007 in participants with AIS undergoing endovascular revascularization.Trial websitePublic notesContactsPrincipal investigatorNameProf Graeme HankeyAddressPerron Institute Chair in Stroke Research, RR Block, QE II Medical Centre, 8 Verdun St, Nedlands, WA 6009CountryAustraliaPhone+61 8 6151 0828FaxContact person for public queriesNameDr Meghan ThomasAddressArgenica Therapeutics Ltd, 4/117 Broadway Nedlands WA 6009, Australia PO Box 1458, West Perth WA 6872CountryAustraliaPhone+61 8 9329 3396FaxContact person for scientific queriesNameDr Meghan ThomasAddressArgenica Therapeutics Ltd, 4/117 Broadway Nedlands WA 6009, Australia. PO Box 1458, West Perth WA 6872CountryAustraliaPhone+61 8 9329 3396FaxData sharing statementWill individual participant data (IPD) for this trial be available (including data dictionaries)?NoNo/undecided IPD sharing reason/commentWhat supporting documents are/will be available?No other documents availableSummary resultsNo Results
- Forums
- ASX - By Stock
- General Discussions
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=...
-
-
- There are more pages in this discussion • 20 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add AGN (ASX) to my watchlist
|
|||||
Last
79.8¢ |
Change
0.013(1.59%) |
Mkt cap ! $99.79M |
Open | High | Low | Value | Volume |
79.8¢ | 79.8¢ | 79.8¢ | $502 | 630 |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
2 | 11000 | 79.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
80.5¢ | 16350 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
2 | 11000 | 0.790 |
2 | 16560 | 0.785 |
1 | 10000 | 0.780 |
1 | 10000 | 0.775 |
3 | 25286 | 0.770 |
Price($) | Vol. | No. |
---|---|---|
0.805 | 16350 | 3 |
0.810 | 15000 | 1 |
0.820 | 26690 | 2 |
0.840 | 8396 | 1 |
0.850 | 9000 | 1 |
Last trade - 12.30pm 11/09/2024 (20 minute delay) ? |
Featured News
AGN (ASX) Chart |