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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083001
|Contact: Marmion Frédéric||+33(0)email@example.com|
|Contact: Polena Viola||33(0)firstname.lastname@example.org|