Clinical trial • Phase III • Ophthalmology|Neurology|Cardiology
TENECTEPLASE for Central retinal artery occlusion
Phase III trial of TENECTEPLASE for Central retinal artery occlusion.
Overview
- Trial Therapeutic Area
- Ophthalmology|Neurology|Cardiology
- Trial Disease
- Central retinal artery occlusion
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 27-09-2024
- First CTIS Authorization Date
- 31-10-2024
Trial design
Randomised, albyl-e 75 mg enterotabletter (acetylsalicylic acid) oral (comparator arm described as asa + placebo; product listed as albyl-e 75 mg enterotabletter). dosing schedule not specified in the summary.-controlled Phase III trial in Belgium, Denmark, Finland and others.
- Randomised
- Yes
- Comparator
- Albyl-E 75 mg enterotabletter (acetylsalicylic acid) oral (comparator arm described as ASA + placebo; product listed as Albyl-E 75 mg enterotabletter). Dosing schedule not specified in the summary.
- Target Sample Size
- 76
- Trial Duration For Participant
- 30
Eligibility
Recruits 76 No vulnerable populations selected. Only adults (Age ≥18). Informed written consent required from each patient. Subject information and informed consent forms for adults are provided (including a Dutch version). No assent procedures described..
- Pregnancy Exclusion
- Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
- Vulnerable Population
- No vulnerable populations selected. Only adults (Age ≥18). Informed written consent required from each patient. Subject information and informed consent forms for adults are provided (including a Dutch version). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- 1.\tNon-arteritic central retinal artery occlusion with ≥ 1.0 logMAR best-corrected visual acuity and symptoms lasting less than 4.5 hours.\n- 2.\tAbility to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.\n- 3.\tAge ≥18 years.\n- 4.\tInformed written consent of the patient.\n- 5.\tA woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given."}
Exclusion criteria
- {"criterion_text":"- 1.\tNo other active intervention targeting CRAO.\n- 2.\tBranch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception).\n- 3.\tSystemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg (2)), despite medical therapy, or clinical suspicion of acute systemic inflammation.\n- 4.\tPresence of intracranial haemorrhage on brain MRI/CT.\n- 5.\tMedical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.\n- 6.\tNo willingness and ability of the patient to participate in all follow-up examinations.\n- 7.\tPregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).\n- 8.\tAllergy or intolerance to any ingredients of IMP (including placebo) or gentamicin or acetylsalicylic acid.\n- 9.\tOther conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).\n- 10.\tSignificant bleeding disorder either at present or within the past 6 months.\n- 11.\tEffective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).\n- 12.\tEffective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.\n- 13.\tAny history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).\n- 14.\tKnown hemorrhagic diathesis.\n- 15.\tMajor surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).\n- 16.\tRecent non-compressible vessel puncture within 2 weeks.\n- 17.\tRecent trauma to the head or cranium.\n- 18.\tProlonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.\n- 19.\tAcute pericarditis and/or subacute bacterial endocarditis.\n- 20.\tAcute pancreatitis.\n- 21.\tSevere hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.\n- 22.\tActive peptic ulceration.\n- 23.\tArterial aneurysm and known arterial/venous malformation.\n- 24.\tNeoplasm with increased bleeding risk.\n- 25.\tAny known history of hemorrhagic stroke or stroke of unknown origin.\n- 26.\tKnown history of ischemic stroke or transient ischemic attack in the preceding 3 months.\n- 27.\tDementia."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Primary endpoint: Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in best-corrected visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).","definition_or_measurement_approach":"Proportion of patients with ≤ 0.7 logMAR best-corrected visual acuity in the affected eye measured at 30 (±5) days after treatment; improvement defined as at least 0.3 logMAR; analysed as intention-to-treat (ITT)."}
Recruitment
- Planned Sample Size
- 76
- Recruitment Window Months
- 63
- Consent Approach
- Informed written consent required from each patient (adults only, Age ≥18). Subject information and informed consent forms for adults are available (L1_SIS and ICF adults documents listed, including a Dutch version). No assent for minors described.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 76
Belgium
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- neurology
- Principal Investigator Name
- Robin Lemmens
- Principal Investigator Email
- robin.lemmens@uzleuven.be
- Contact Person Name
- Robin Lemmens
- Contact Person Email
- robin.lemmens@uzleuven.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 04-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- Aarhus Universitet
- Department Name
- Neurology
- Principal Investigator Name
- Claus Ziegler Simonsen
- Principal Investigator Email
- clausimo@rm.dk
- Contact Person Name
- Claus Ziegler Simonsen
- Contact Person Email
- clausimo@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Neurology
- Principal Investigator Name
- Thomas Clement Truelsen
- Principal Investigator Email
- thomas.clement.truelsen@regionh.dk
- Contact Person Name
- Thomas Clement Truelsen
- Contact Person Email
- thomas.clement.truelsen@regionh.dk
- Site Name
- Copenhagen University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Louisa Marguerite Christensen
- Principal Investigator Email
- louisa.marguerite.christensen@regionh.dk
- Contact Person Name
- Louisa Marguerite Christensen
- Contact Person Email
- louisa.marguerite.christensen@regionh.dk
Finland
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 01-11-2024
- Processing Time Days
- 8
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Neurology
- Principal Investigator Name
- Petra Ijäs
- Principal Investigator Email
- Petra.Ijas@hus.fi
- Contact Person Name
- Petra Ijäs
- Contact Person Email
- Petra.Ijas@hus.fi
- Site Name
- Turku University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Pauli Ylikotila
- Principal Investigator Email
- Pauli.ylikotila@tyks.fi
- Contact Person Name
- Pauli Ylikotila
- Contact Person Email
- Pauli.ylikotila@tyks.fi
Ireland
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 31-10-2024
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Sean Murphy
- Principal Investigator Email
- seanmurphy@mater.ie
- Contact Person Name
- Sean Murphy
- Contact Person Email
- seanmurphy@mater.ie
Sweden
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 31-10-2024
- Processing Time Days
- 7
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Region Vaesternorrland
- Department Name
- Neurology
- Principal Investigator Name
- Fredrik Björck
- Principal Investigator Email
- fredrik.bjork@rvn.se
- Contact Person Name
- Fredrik Björck
- Contact Person Email
- fredrik.bjork@rvn.se
- Site Name
- Karolinska Institutet
- Department Name
- Neurology
- Principal Investigator Name
- Michael Mazya
- Principal Investigator Email
- michael.mazya@regionstockholm.se
- Contact Person Name
- Michael Mazya
- Contact Person Email
- michael.mazya@regionstockholm.se
Norway
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 05-11-2024
- Processing Time Days
- 12
- Number Of Sites
- 9
- Number Of Participants
- 29
Sites
- Site Name
- Sykehuset Telemark HF
- Department Name
- Neurology
- Principal Investigator Name
- Vetle Nilsen Malmberg
- Principal Investigator Email
- vetmal@sthf.no
- Contact Person Name
- Vetle Nilsen Malmberg
- Contact Person Email
- vetmal@sthf.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Neurology
- Principal Investigator Name
- Hanne Ellekjær
- Principal Investigator Email
- hanne.ellekjar@ntnu.no
- Contact Person Name
- Hanne Ellekjær
- Contact Person Email
- hanne.ellekjar@ntnu.no
- Site Name
- Helse Stavanger HF
- Department Name
- Neurology
- Principal Investigator Name
- Martin Kurz
- Principal Investigator Email
- friedrich.martin.wilhelm.kurz@sus.no
- Contact Person Name
- Martin Kurz
- Contact Person Email
- friedrich.martin.wilhelm.kurz@sus.no
- Site Name
- Helse Bergen HF
- Department Name
- Neurology
- Principal Investigator Name
- Andrej Khanevski
- Principal Investigator Email
- andrej.netland.khanevski@helse-bergen.no
- Contact Person Name
- Andrej Khanevski
- Contact Person Email
- andrej.netland.khanevski@helse-bergen.no
- Site Name
- Sykehuset Innlandet HF
- Department Name
- Neurology
- Principal Investigator Name
- Anette Huuse Farmen
- Principal Investigator Email
- anette.huuse.farmen@sykehuset-innlandet.no
- Contact Person Name
- Anette Huuse Farmen
- Contact Person Email
- anette.huuse.farmen@sykehuset-innlandet.no
- Site Name
- Vestre Viken HF
- Department Name
- Neurology
- Principal Investigator Name
- Kristin Evensen
- Principal Investigator Email
- SBEVEK@vestreviken.no
- Contact Person Name
- Kristin Evensen
- Contact Person Email
- SBEVEK@vestreviken.no
- Site Name
- Sykehuset I Vestfold HF
- Department Name
- Neurology
- Principal Investigator Name
- Håvard Lisether
- Principal Investigator Email
- haalis@siv.no
- Contact Person Name
- Håvard Lisether
- Contact Person Email
- haalis@siv.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Neurology
- Principal Investigator Name
- Anne Hege Aamodt
- Principal Investigator Email
- anhaam@ous-hf.no
- Contact Person Name
- Anne Hege Aamodt
- Contact Person Email
- anhaam@ous-hf.no
- Site Name
- Sykehuset Oestfold HF Kalnes
- Department Name
- Ophthalmology
- Principal Investigator Name
- Oddbjørn Bjordal
- Principal Investigator Email
- oddbjorn.bjordal@so-hf.no
- Contact Person Name
- Oddbjørn Bjordal
- Contact Person Email
- oddbjorn.bjordal@so-hf.no
Sponsor
Primary sponsor
- Full Name
- Oslo University Hospital HF
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Norway
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"[{\"id\":421516,\"code\":\"1\"}]","organisation_type":"Educational Institution"}
- {"country":"Denmark","full_name":"Rigshospitalet","duties_or_roles":"[{\"id\":421515,\"code\":\"1\"}]","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- TENECTEPLASE
- Active Substance
- TENECTEPLASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS INJECTION
- Route
- INTRAVENOUS INJECTION
- Authorisation Status
- 2
- Starting Dose
- 0.25 mg/kg
- Dose Levels
- 0.25 mg/kg
- Maximum Dose
- 25 mg
- Investigational Product Name
- Albyl-E 75 mg enterotabletter
- Active Substance
- ACETYLSALICYLIC ACID
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- 2
- Starting Dose
- 75 mg
- Dose Levels
- 75 mg (product listed as 75 mg enterotabletter); max daily dose reported 300 mg
- Maximum Dose
- 300 mg
- Investigational Product Name
- Sodium Chloride Fresenius Kabi Italia 0.9 % Solution for infusion
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- 2
- Maximum Dose
- 25 mg
- Investigational Product Name
- encapsulated tablets of inactive substance
- Modality
- Other
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