Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open, Study to Assess the Safety of RGTA® (OTR4132) in Patients With Acute Ischemic Stroke (AIS) (MATRISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083001
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborators:
European Commission
EURAXI
Information provided by (Responsible Party):
Organ, Tissue, Regeneration, Repair and Replacement

Brief Summary:

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

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: open study
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: OTR4132MD

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.

Device: OTR4132MD

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.





Primary Outcome Measures :
  1. Rate of severe adverse events device related and dose limiting [ Time Frame: 7 Days ]
    Severe adverse events


Secondary Outcome Measures :
  1. Survival rates [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]
    survival rates

  2. All cause death [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]
    All cause death

  3. Stroke related death [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]
    Stroke related death

  4. 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

  5. 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

  6. Symptomatic intracranial haemorrhage [ Time Frame: 24 hours, 7 Days, 30 Days, 90 Days ]
    Intracranial haemorrhage

  7. Brain oedema on 24-hour follow-up imaging [ Time Frame: 24 hours ]
    brain oedema

  8. New ischaemic lesions [ Time Frame: 24 hours ]
    Ischaemic lesions in new territories on 24-hours follow-up imaging


Other Outcome Measures:
  1. Revascularization on 24-hour follow-up imaging [ Time Frame: 24 Hours ]
    Revascularization on 24-hour follow-up imaging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Eligible patients for this study will be included if all of the following conditions are met:

    1. Age 18 to 80 years
    2. Acute ischemic stroke in anterior circulation territory, identified by magnetic resonance imaging (MRI)
    3. Occlusion of anterior circulation i.e. internal carotid artery or proximal middle cerebral artery (MCA) (M1, M1/M2)
    4. Volume of the lesion estimated below two third of the MCA territory
    5. Intravenous (IV) thrombolysis performed according to European Stroke Organization (ESO) guidelines
    6. Intravenous Alteplase (1h infusion) terminated at least 40min before effective thrombectomy; or Intravenous Tenecteplase (bolus) terminated at least 120min before effective thrombectomy
    7. Endovascular thrombectomy initiated within 6 hours of stroke onset
    8. Angiography after endovascular treatment: TICI grade 2b - 3
    9. Baseline NIHSS (National Institute of Health Stroke Score), including hand testing 11 and 25 at screening
    10. No significant pre-stroke disability (pre-baseline modified Rankin Score (mRS) 0-1)
    11. Able to follow neuro-rehabilitation programme
    12. Patient* or legally authorized representative (family member, trusted person or physician) if patient unable to give consent has signed informed consent.

      • Patients unable to give consent at baseline will go through a deferred consent procedure to continue the study (Section 12: Subject Information and Informed Consent)

Exclusion Criteria:

  • Eligible patients for this study will not be included if any of the following conditions are present:

    1. Previous symptomatic stroke
    2. Pre-existing medical, neurological or psychiatric disease that would confound the neurological evaluation
    3. Contra-indication to MRI
    4. Evidence of intracranial haemorrhage (ICH)
    5. At the discretion of the investigator, patients with co-morbidities associated with a life expectancy of less than 3 months or co-morbidities that could influence the study results or would complicate assessment of outcomes (e.g. dementia, psychiatric disease) or would make clinical follow-up difficult
    6. History of allergy or anaphylactic reactions to any of the ingredients of OTR4132-MD or heparinoids
    7. Severe renal failure with glomerular filtration rate (GFR) < 30 mL/min
    8. Severe uncontrolled arterial hypertension e.g. systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, or intravenous medication necessary to reduce blood pressure
    9. Increased risk of haemorrhage (such as medical history of significant bleeding disorders, major surgery or significant trauma in the past 3 months, any history of central nervous damage or suspected intracranial haemorrhage, symptoms suggestive of subarachnoid haemorrhage, even if the MRI is normal, international normalized ratio (INR)>1.3 or activated partial thromboplastin time (aPTT)>ULN (upper limit of normal)
    10. Suspected cerebral vasculitis based on medical history and imaging
    11. Occlusions in multiple vascular territories
    12. Evidence of intracranial tumour
    13. Evidence of any prior intracranial intervention (i.e. neurosurgery, endovascular intervention)
    14. Worsening of medical or neurological conditions or per-procedures complications
    15. Any other serious, advanced, or terminal illness (investigator judgment)
    16. Pregnant or breastfeeding or women without an adequate contraceptive method
    17. Current participation in another investigation drug or device study
    18. The patient is not a member or beneficiary of a social security scheme

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Marmion Frédéric +33(0)183628545 frederic.marmion@otr3.com
Contact: Polena Viola 33(0)183628545 viola.polena@otr3.com

Sponsors and Collaborators
Organ, Tissue, Regeneration, Repair and Replacement
European Commission
EURAXI

Layout table for additonal information
Responsible Party: Organ, Tissue, Regeneration, Repair and Replacement
ClinicalTrials.gov Identifier: NCT04083001     History of Changes
Other Study ID Numbers: 2018-A03117-48
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Organ, Tissue, Regeneration, Repair and Replacement:
Stroke
FIM
OTR3
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases