Clinical trial • Phase III • Cardiology | Neurology

TENECTEPLASE for Acute ischemic stroke

Phase III trial of TENECTEPLASE for Acute ischemic stroke.

Overview

Trial Therapeutic Area
Cardiology | Neurology
Trial Disease
Acute ischemic stroke
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
04-11-2025
First CTIS Authorization Date
11-03-2026

Trial design

Randomised, open-label, standard of care (soc) comparator arm; no specific drug name, dose, or schedule specified for soc in the ctis json-controlled Phase III trial in Bulgaria, Hungary, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care (SOC) comparator arm; no specific drug name, dose, or schedule specified for SOC in the CTIS JSON
Target Sample Size
999
Trial Duration For Participant
90

Eligibility

Recruits 999 Vulnerable population selected (isVulnerablePopulationSelected = true). Inclusion requires a signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission; participants must be ≥18 years old (or legal age of consent where higher). No specific assent or proxy-consent wording is provided in the CTIS JSON..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Inclusion requires a signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission; participants must be ≥18 years old (or legal age of consent where higher). No specific assent or proxy-consent wording is provided in the CTIS JSON.

Inclusion criteria

  • {"criterion_text":"- Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. See Section 8.1 for details.\n- Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation, last known well >4.5 h before time of presumed randomisation\n- Pre-stroke mRS ≤1 (to be assessed via medical history)\n- Imaging eligibility by MRI CT"}

Exclusion criteria

  • {"criterion_text":"- Intention to proceed to MT at the same site (hospital) of randomisation.\n- Occlusion of the internal carotid artery (ICA)\n- High-risk patients (increased risk of thrombolysis related hemorrhage)\n- Any intracranial hemorrhage detected on NCCT or MRI scans\n- Contra-indication to contrast brain imaging with CT and MRI\n- Severe stroke as assessed clinically (NIHSS > 25)\n- Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator\n- Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h\n- Patients scheduled to receive i.v. thrombolysis as standard of care\n- Other known history of or identified relevant central nervous system damage (i.e., neoplasm, arterial aneurysm and/or arterial/venous malformation, intracranial or spinal surgery) as well as known arterial aneurysm and/or arterial/venous malformations, and/or neoplasms with increased bleeding risk, located outside of the Central Nervous System.\n- Contra-indications to Tenecteplase"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- mRS 0-1 at Day 90","definition_or_measurement_approach":"Modified Rankin Scale (mRS) score of 0-1 at Day 90 (excellent functional outcome)"}

Secondary endpoints

  • {"endpoint_text":"- mRS (ordinal) at Day 90","definition_or_measurement_approach":"Ordinal analysis of the modified Rankin Scale at Day 90"}
  • {"endpoint_text":"- Early neurological improvement (reduction in acute – 24-hour NIHSS score of ≥8 or value of 0/1)","definition_or_measurement_approach":"Reduction in acute (24-hour) NIHSS score of ≥8 or NIHSS value of 0 or 1 at 24 hours"}
  • {"endpoint_text":"- mRS 0-2 at Day 90","definition_or_measurement_approach":"Modified Rankin Scale score of 0-2 at Day 90"}
  • {"endpoint_text":"- sICH as defined by SITS-MOST criteria at 36 h","definition_or_measurement_approach":"Symptomatic intracerebral hemorrhage as defined by SITS-MOST criteria assessed at 36 hours"}
  • {"endpoint_text":"- sICH as defined by ECASS III criteria at 36 h","definition_or_measurement_approach":"Symptomatic intracerebral hemorrhage as defined by ECASS III criteria assessed at 36 hours"}
  • {"endpoint_text":"- Death from any cause within 90 days","definition_or_measurement_approach":"All-cause mortality assessed within 90 days of randomisation"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
999
Recruitment Window Months
17
Consent Approach
Signed and dated written informed consent required prior to admission to the trial in accordance with ICH-GCP and local legislation. Participants must be ≥18 years old (or at least the legal age of consent where higher). Informed consent forms and subject information materials are available in multiple languages (documents in English, Bulgarian, Greek, Hungarian, Romanian, Spanish, Norwegian and other local-language versions are listed in the CTIS documents). No detailed proxy-consent or assent procedure text is provided in the CTIS JSON.

Methods

  • Site posters (K2_Recruitment Material_Site Poster) - site-based recruitment materials
  • Participant brochure (K2_Recruitment Material_Participant Brochure) - participant-facing printed materials
  • Clinical Studies Brochure (K2_Clinical Studies Brochure) - informational brochure for sites/participants
  • Emergency Letter (K2_Recruitment material_Emergency Letter) - site emergency contact letter
  • Recruitment arrangements and informed consent procedure (K1_Recruitment arrangements) - documented recruitment/informed consent workflow
  • Animation Video Storyboard (L2_Animation Video Storyboard) - audiovisual storyboard for participant information
  • Participant ID Card and Study Guides (L2_Other subject information material_Participant ID Card, Participant Study Guide)
  • Talking Points Guide and Site materials (Talking Points Guide) - for site staff engagement
  • Surveys and feedback with QR-code/email (multiple L2 survey documents) - participant and caregiver feedback mechanisms

Geography

Total Number Of Sites
54
Total Number Of Participants
326

Bulgaria

Earliest CTIS Part Ii Submission Date
09-02-2026
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
32
Number Of Sites
15
Number Of Participants
53

Sites

Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Second Clinic of neurology diseases
Principal Investigator Name
Ivan Dimitrov
Principal Investigator Email
i.dimitrov.bs@heartandbrain.bg
Contact Person Name
Ivan Dimitrov
Contact Person Email
i.dimitrov.bs@heartandbrain.bg
Site Name
University Hospital St. Anna
Department Name
Clinic of neurology diseases
Principal Investigator Name
Rosen Kalpachki
Principal Investigator Email
neurozona@gmail.com
Contact Person Name
Rosen Kalpachki
Contact Person Email
neurozona@gmail.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
Department of neurology diseases
Principal Investigator Name
Ivan Ivanov
Principal Investigator Email
ivanov@mcmedicaplus.com
Contact Person Name
Ivan Ivanov
Contact Person Email
ivanov@mcmedicaplus.com
Site Name
Multiprofessional Hospital For Active Treatment City Clinic Saint Georgi Ltd
Department Name
Department of neurology diseases
Principal Investigator Name
Elena Dimitrova
Principal Investigator Email
elenadimitrova_md@abv.bg
Contact Person Name
Elena Dimitrova
Contact Person Email
elenadimitrova_md@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of neurology diseases
Principal Investigator Name
Penka Atanasova
Principal Investigator Email
p_a7@abv.bg
Contact Person Name
Penka Atanasova
Contact Person Email
p_a7@abv.bg
Site Name
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department Name
Department of neurology diseases
Principal Investigator Name
Sasho Kastrev
Principal Investigator Email
kastrev@hotmail.com
Contact Person Name
Sasho Kastrev
Contact Person Email
kastrev@hotmail.com
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Clinic of neurology diseases
Principal Investigator Name
Mariya Dimitrova
Principal Investigator Email
dr.m.i.dimitrova@gmail.com
Contact Person Name
Mariya Dimitrova
Contact Person Email
dr.m.i.dimitrova@gmail.com
Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Clinic for intensive treatment of neurology diseases
Principal Investigator Name
Milena Milanova
Principal Investigator Email
milanova_m@dir.bg
Contact Person Name
Milena Milanova
Contact Person Email
milanova_m@dir.bg
Site Name
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
Department Name
Department of neurology diseases
Principal Investigator Name
Tanya Beleva
Principal Investigator Email
tbb.n@abv.bg
Contact Person Name
Tanya Beleva
Contact Person Email
tbb.n@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Kaspela EOOD
Department Name
Department of neurology diseases
Principal Investigator Name
Valcho Naydenov
Principal Investigator Email
val.nay@mail.bg
Contact Person Name
Valcho Naydenov
Contact Person Email
val.nay@mail.bg
Site Name
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Department Name
Clinic of neurology diseases
Principal Investigator Name
Plamen Bozhinov
Principal Investigator Email
psbozhinov@yahoo.com
Contact Person Name
Plamen Bozhinov
Contact Person Email
psbozhinov@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Principal Investigator Name
Danovska-Mladenova Maya
Principal Investigator Email
mdanovska@yahoo.com
Contact Person Name
Danovska-Mladenova Maya
Contact Person Email
mdanovska@yahoo.com
Site Name
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD
Department Name
Clinic of neurology diseases
Principal Investigator Name
Dimitar Maslarov
Principal Investigator Email
maslarovdb@abv.bg
Contact Person Name
Dimitar Maslarov
Contact Person Email
maslarovdb@abv.bg
Site Name
Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie Medika Ruse OOD
Department Name
Department of neurology diseases
Principal Investigator Name
Rositsa Krasteva
Principal Investigator Email
rosikrasteva@abv.bg
Contact Person Name
Rositsa Krasteva
Contact Person Email
rosikrasteva@abv.bg
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
Clinic of Neurology and Sleep Medicine
Principal Investigator Name
Ivan Staikov
Principal Investigator Email
ivanstaikov@hotmail.com
Contact Person Name
Ivan Staikov
Contact Person Email
ivanstaikov@hotmail.com

Hungary

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
50
Number Of Sites
8
Number Of Participants
41

Sites

Site Name
University Of Pecs
Department Name
Neurológiai Klinika
Principal Investigator Name
László Szapáry
Principal Investigator Email
szapary.laszlo@pte.hu
Contact Person Name
László Szapáry
Contact Person Email
szapary.laszlo@pte.hu
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Neurológiai osztály
Principal Investigator Name
Géza Szilágyi
Principal Investigator Email
szilagyi.geza@uzsoki.hu
Contact Person Name
Géza Szilágyi
Contact Person Email
szilagyi.geza@uzsoki.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Neurológia
Principal Investigator Name
Levente Kerényi
Principal Investigator Email
lkerenyi@mail.fmkorhaz.hu
Contact Person Name
Levente Kerényi
Contact Person Email
lkerenyi@mail.fmkorhaz.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Neurológia - Stroke osztály
Principal Investigator Name
Lajos Varannai
Principal Investigator Email
dr.varannai.lajos@szszbmk.hu
Contact Person Name
Lajos Varannai
Contact Person Email
dr.varannai.lajos@szszbmk.hu
Site Name
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz
Department Name
Stroke,Vascularis és Altalános Neurológiai és Toxikológiai Osztály
Principal Investigator Name
Attila Valikovics
Principal Investigator Email
valikovics.idegtox@bazmkorhaz.hu
Contact Person Name
Attila Valikovics
Site Name
University Of Szeged
Department Name
Neurológiai Klinika
Principal Investigator Name
Péter Klivényi
Principal Investigator Email
klivenyi.peter@med.u-szeged.hu
Contact Person Name
Péter Klivényi
Contact Person Email
klivenyi.peter@med.u-szeged.hu
Site Name
Semmelweis University
Department Name
Neurológiai Klinika
Principal Investigator Name
Dániel Bereczki
Principal Investigator Email
bereczki.daniel@semmelweis.hu
Contact Person Name
Dániel Bereczki
Contact Person Email
bereczki.daniel@semmelweis.hu
Site Name
Kistarcsai Flor Ferenc Korhaz
Department Name
Neurologia és Stroke Osztály
Principal Investigator Name
Gyula Pánczél
Principal Investigator Email
panczel.gyula@florhosp.hu
Contact Person Name
Gyula Pánczél
Contact Person Email
panczel.gyula@florhosp.hu

Spain

Earliest CTIS Part Ii Submission Date
06-02-2026
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
33
Number Of Sites
16
Number Of Participants
89

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Neurology
Principal Investigator Name
Nicolás López Hernández
Principal Investigator Email
lopez_nic@gva.es
Contact Person Name
Nicolás López Hernández
Contact Person Email
lopez_nic@gva.es
Site Name
Hospital Universitari De Girona Doctor Josep Trueta
Department Name
Neurology
Principal Investigator Name
Yolanda Silva Blas
Principal Investigator Email
ysilva.girona.ics@gencat.cat
Contact Person Name
Yolanda Silva Blas
Contact Person Email
ysilva.girona.ics@gencat.cat
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurology
Principal Investigator Name
Meritxell Gomis Cortina
Principal Investigator Email
mgomis.germanstrias@gencat.cat
Contact Person Name
Meritxell Gomis Cortina
Contact Person Email
mgomis.germanstrias@gencat.cat
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Neurology
Principal Investigator Name
Jerzy Krupinski
Principal Investigator Email
jkrupinski@mutuaterrassa.es
Contact Person Name
Jerzy Krupinski
Contact Person Email
jkrupinski@mutuaterrassa.es
Site Name
Hospital Universitario De Cruces
Department Name
Neurology
Principal Investigator Name
María del Mar Freijo Guerrero
Principal Investigator Email
mariadelmar.freijoguerrero@osakidetza.eus
Contact Person Name
María del Mar Freijo Guerrero
Site Name
Hospital Clinico San Carlos
Department Name
Neurology
Principal Investigator Name
José Antonio Egido Herrero
Principal Investigator Email
jegidoh@yahoo.com
Contact Person Name
José Antonio Egido Herrero
Contact Person Email
jegidoh@yahoo.com
Site Name
Hospital Del Mar
Department Name
Neurology
Principal Investigator Name
Ana Rodríguez Campello
Principal Investigator Email
arodriguezc@parcdesalutmar.cat
Contact Person Name
Ana Rodríguez Campello
Contact Person Email
arodriguezc@parcdesalutmar.cat
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Neurology
Principal Investigator Name
Pol Camps Renom
Principal Investigator Email
pcamps@santpau.cat
Contact Person Name
Pol Camps Renom
Contact Person Email
pcamps@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Neurology
Principal Investigator Name
Patricia Calleja Castaño
Principal Investigator Email
patricia.calleja@salud.madrid.org
Contact Person Name
Patricia Calleja Castaño
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Neurology
Principal Investigator Name
Miguel Ángel Gamero García
Principal Investigator Email
gamero.ma@gmail.com
Contact Person Name
Miguel Ángel Gamero García
Contact Person Email
gamero.ma@gmail.com
Site Name
Hospital Ruber Juan Bravo
Department Name
Neurology
Principal Investigator Name
Rafael Arroyo González
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo González
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Neurology
Principal Investigator Name
Alejandro Ponz de Tienda
Principal Investigator Email
ponz_ale@gva.es
Contact Person Name
Alejandro Ponz de Tienda
Contact Person Email
ponz_ale@gva.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
Carlos Molina Cateriano
Principal Investigator Email
carlosav.molina@vallhebron.cat
Contact Person Name
Carlos Molina Cateriano
Contact Person Email
carlosav.molina@vallhebron.cat
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Neurology
Principal Investigator Name
Andrés García Pastor
Principal Investigator Email
agpastor@salud.madrid.org
Contact Person Name
Andrés García Pastor
Contact Person Email
agpastor@salud.madrid.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurology
Principal Investigator Name
María del Mar Castellanos Rodrigo
Contact Person Name
María del Mar Castellanos Rodrigo
Site Name
Bellvitge University Hospital
Department Name
Neurology
Principal Investigator Name
Pedro Cardona Portela
Principal Investigator Email
pcardonap@bellvitgehospital.cat
Contact Person Name
Pedro Cardona Portela

Norway

Earliest CTIS Part Ii Submission Date
11-02-2026
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
33
Number Of Sites
2
Number Of Participants
20

Sites

Site Name
Sykehuset Ostfold HF
Department Name
Department of Neurology
Principal Investigator Name
Monika Mochol
Principal Investigator Email
monika.mochol@so-hf.no
Contact Person Name
Monika Mochol
Contact Person Email
monika.mochol@so-hf.no
Site Name
Helse Stavanger HF
Department Name
Department of Neurology
Principal Investigator Name
Martin Kurz
Principal Investigator Email
martin.kurz@sus.no
Contact Person Name
Martin Kurz
Contact Person Email
martin.kurz@sus.no

Romania

Earliest CTIS Part Ii Submission Date
18-11-2025
Latest Decision Or Authorization Date
17-03-2026
Processing Time Days
119
Number Of Sites
6
Number Of Participants
68

Sites

Site Name
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Department Name
Sectia Neurologie
Principal Investigator Name
Daniela Beatrice Neagu
Principal Investigator Email
neagudaniela@ymail.com
Contact Person Name
Daniela Beatrice Neagu
Contact Person Email
neagudaniela@ymail.com
Site Name
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Department Name
Sectia Clinica Neurologie
Principal Investigator Name
Any Axelerad
Principal Investigator Email
docuaxi@yahoo.com
Contact Person Name
Any Axelerad
Contact Person Email
docuaxi@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Sectia Clinica Neurologie I
Principal Investigator Name
Rodica Ioana Balasa
Principal Investigator Email
rodica.balasa@umfst.ro
Contact Person Name
Rodica Ioana Balasa
Contact Person Email
rodica.balasa@umfst.ro
Site Name
Spitalului Judetean De Urgenta Piatra Neamt
Department Name
Sectia Neurologie
Principal Investigator Name
Rodica Gurau
Principal Investigator Email
rgurau@gmail.com
Contact Person Name
Rodica Gurau
Contact Person Email
rgurau@gmail.com
Site Name
Spitalul Clinic Judetean De Urgenta Brasov
Department Name
Sectia Clinica Neurologie
Principal Investigator Name
Cristian Falup-Pecurariu
Principal Investigator Email
crisfp100@yahoo.co.uk
Contact Person Name
Cristian Falup-Pecurariu
Contact Person Email
crisfp100@yahoo.co.uk
Site Name
Spitalul Clinic Județean De Urgența Arad
Department Name
Sectia Neurologie
Principal Investigator Name
Catalin Hreniuc
Principal Investigator Email
secretariat@scjarad.ro
Contact Person Name
Catalin Hreniuc
Contact Person Email
secretariat@scjarad.ro

Greece

Earliest CTIS Part Ii Submission Date
15-12-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
86
Number Of Sites
7
Number Of Participants
55

Sites

Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
Neurology Clinic
Principal Investigator Name
Rudolf Jobst
Principal Investigator Email
jobstrudolf@hotmail.com
Contact Person Name
Rudolf Jobst
Contact Person Email
jobstrudolf@hotmail.com
Site Name
Eginitio Hospital
Department Name
1st Department of Neurology
Principal Investigator Name
Sofia Vassilopoulou
Principal Investigator Email
svassilopoulou@gmail.com
Contact Person Name
Sofia Vassilopoulou
Contact Person Email
svassilopoulou@gmail.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
2nd Department of Neurology
Principal Investigator Name
Theodoros Karapanayiotides
Principal Investigator Email
tkarapanayiotides@yahoo.gr
Contact Person Name
Theodoros Karapanayiotides
Contact Person Email
tkarapanayiotides@yahoo.gr
Site Name
Athens Euroclinic S.A.
Department Name
Neurology Department
Principal Investigator Name
Vaso Zisimopoulou
Principal Investigator Email
vzisimopoulou@gmail.com
Contact Person Name
Vaso Zisimopoulou
Contact Person Email
vzisimopoulou@gmail.com
Site Name
Athens Naval Hospital
Department Name
Neurology Department
Principal Investigator Name
Michail Ioakeimidis
Principal Investigator Email
michael_ioakeimidis@hotmail.com
Contact Person Name
Michail Ioakeimidis
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
Second Department of Neurology
Principal Investigator Name
Georgios Tsivgoulis
Principal Investigator Email
tsivgoulisgiorg@yahoo.gr
Contact Person Name
Georgios Tsivgoulis
Contact Person Email
tsivgoulisgiorg@yahoo.gr
Site Name
General University Hospital Of Patras
Department Name
Neurology Clinic
Principal Investigator Name
John Ellul
Principal Investigator Email
ellul@upatras.gr
Contact Person Name
John Ellul
Contact Person Email
ellul@upatras.gr

Sponsor

Primary sponsor

Full Name
Boehringer Ingelheim International GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
IQVIA Limited
Responsibilities
sponsorDuties codes: 1,11,12,13,14,2,5,8
Name
Cronos Clinical Consulting Services, Inc.
Responsibilities
Scale Management, Rater Services, Translations
Name
Perceptive Informatics Inc.
Responsibilities
sponsorDuties code: 3
Name
Clario
Responsibilities
MRI,CTs
Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties code: 14
Name
Veeva Systems Inc.
Responsibilities
sponsorDuties code: 7
Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
sponsorDuties codes: 1,12,2,8

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1,11,12,13,14,2,5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cronos Clinical Consulting Services, Inc.","duties_or_roles":"Scale Management, Rater Services, Translations","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Clario","duties_or_roles":"MRI,CTs","organisation_type":"Health care"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"sponsorDuties codes: 1,12,2,8","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Metalyse 5 000 units (25 mg) powder for solution for injection
Active Substance
TENECTEPLASE
Modality
Peptide/protein/enzyme
Routes Of Administration
Intravenous bolus
Route
Intravenous bolus
Authorisation Status
Authorised (marketing authorisation EU/1/00/169/007)
Starting Dose
0.25 mg/kg (maximum 25 mg)
Dose Levels
0.25 mg/kg (maximum 25 mg)
Frequency
Single administration (one-time intravenous bolus)
Maximum Dose
25 mg

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