An Open, Study to Assess the Safety of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS) (MATRISS)
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|ClinicalTrials.gov Identifier: NCT04083001|
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
RGTA® (ReGeneraTing Agent) are synthetic polysaccharides mimicking extra-cellular matrix scaffold elements and protective agents called Heparan Sulphates (HSPGs).
OTR4132-MD is provided as a sterile injectable medical device. OTR4132-MD is indicated in anterior circulation acute ischemic stroke (AIS) patients re-vascularized (TICI score 2b - 3) by combined thrombolysis and endovascular thrombectomy within 6 hours of symptoms onset.
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Device: OTR4132MD||Not Applicable|
The promising results of OTR4132-MD in the treatment of acute ischemic stroke in animal studies and the excellent results of biocompatibility tests reported in the Investigator's Brochure allowed to design a clinical investigation in humans named MATRISS. As this is a First-In-Man (FIM) study assessing OTR4132-MD, it is designed as a single ascending dose (SAD) to evaluate the safety, tolerability of a single intra-arterial injection of OTR4132-MD in AIS patients treated with combined thrombolysis and thrombectomy.
The FIM will include up to 18 patients in up to five dose groups. Each group will comprise 3 subjects. This FIM study will also monitor a dose response relationship in humans: lesion volume change throughout the study period. Patients will be given a single intra-arterial injection of OTR4132-MD with a predefined dose of OTR4132. In the first dose group, the OTR4132 dose is 0.20 mg.
The results of this study will serve as a groundwork for the design of a pivotal study in the intended patient population.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open study|
|Masking:||None (Open Label)|
|Official Title:||An Open, Multi-centre Study to Assess the Safety and Tolerability of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS)|
|Estimated Study Start Date :||December 15, 2019|
|Estimated Primary Completion Date :||January 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
one medical device (10mL) of one of the 5 available concentrations (20 μg/mL, 50 μg/mL, 100 μg/mL, 150 μg/mL, 200 μg/mL) will be administrated as a one shot-dose to the patient.
The respective total dose of OTR4132 received by a patient will be one of the following: 0,20 mg, 0,50 mg, 1 mg, 1,5 mg and 2 mg.
According to Regulation (EU) 2017/745(MDR), OTR4132-MD is an implantable medical device, for short term use which is specifically intended for use in direct contact with systemic circulation system.
OTR4132-MD is by definition intended to come into contact with the patient when being injected. It is administered through intra-arterial injection, in an one-shot dose and the majority of the product is eliminated within 24 hours.
- Rate of severe adverse events device related and dose limiting [ Time Frame: 7 Days ]Severe adverse events
- Survival rates [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]survival rates
- All cause death [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]All cause death
- Stroke related death [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]Stroke related death
- Rate of device related adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]rate of device related adverse events
- Rate of adverse events (AEs) and serious adverse events (SAEs) procedure related [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]Rate of AEs and SAEs propcedure related
- Symptomatic intracranial haemorrhage [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]Intracranial haemorrhage
- Brain oedema on 24-hour follow-up imaging [ Time Frame: 24 hours ]brain oedema
- New ischaemic lesions [ Time Frame: 24 hours ]Ischaemic lesions in new territories on 24-hours follow-up imaging
- Revascularization on 24-hour follow-up imaging [ Time Frame: 24 Hours ]Revascularization on 24-hour follow-up imaging
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083001
|Contact: Marmion Frédéric||+33(0)firstname.lastname@example.org|
|Contact: Polena Viola||33(0)email@example.com|