Clinical trial • Phase II • Respiratory

HUMAN PLASMA GELSOLIN, RECOMBINANT for Acute respiratory distress syndrome (ARDS)

Phase II trial of HUMAN PLASMA GELSOLIN, RECOMBINANT for Acute respiratory distress syndrome (ARDS).

Overview

Trial Therapeutic Area
Respiratory
Trial Disease
Acute respiratory distress syndrome (ARDS)
Trial Stage
Phase II
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
29-07-2024
First CTIS Authorization Date
18-11-2024

Trial design

Randomised, placebo, 0.9% saline solution; dose/schedule not specified (placebo arm: soc treatment + placebo)-controlled Phase II trial in Hungary, Romania, Bulgaria and others.

Randomised
Yes
Comparator
Placebo, 0.9% saline solution; dose/schedule not specified (placebo arm: SoC treatment + placebo)
Target Sample Size
228
Trial Duration For Participant
60

Eligibility

Recruits 228 Vulnerable population considerations: the trial includes critically ill subjects (ARDS) and indicates that informed consent may be obtained from the subject, next of kin or legal proxy. Country-specific informed consent and legal representative/trusted person forms are provided (e.g., 'L1_Spouse and LR ICF_DE', 'L1_Recovered Capacity ICF_DE', 'L1_FR_ICF_Trusted Person_fr', 'L1_NL_Legal Representative_SIS ICF'). The documentation set includes legal representative/trusted person and recovered-capacity consent forms indicating provisions for proxy consent when subjects lack capacity..

Pregnancy Exclusion
4. Pregnant or lactating women.
Vulnerable Population
Vulnerable population considerations: the trial includes critically ill subjects (ARDS) and indicates that informed consent may be obtained from the subject, next of kin or legal proxy. Country-specific informed consent and legal representative/trusted person forms are provided (e.g., 'L1_Spouse and LR ICF_DE', 'L1_Recovered Capacity ICF_DE', 'L1_FR_ICF_Trusted Person_fr', 'L1_NL_Legal Representative_SIS ICF'). The documentation set includes legal representative/trusted person and recovered-capacity consent forms indicating provisions for proxy consent when subjects lack capacity.

Inclusion criteria

  • {"criterion_text":"- 1. Infection followed within a week of documented bilateral infiltrates/opacities consistent with ARDS, as assessed by the admitting emergency department, clinic, intensivist, or ward physician or equivalent caregiver or a radiologist: - Investigator or designee to note radiologic findings in the electronic case report form (eCRF); - Radiology report and conclusion should be summarized in the eCRF; - A digital copy of the radiograph saved for review.\n- 2. Acute hypoxemic respiratory failure (moderate-to-severe ARDS) for ≤48 hours associated with suspected or confirmed infection (moderate-to-severe ARDS defined by the ratio of arterial pressure of O2 to the fraction of inspired O2 ≤150 in any position). Eligible subjects will be intubated for mechanical ventilation, receiving noninvasive ventilation by continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or on HFNO at least 30 L/min of 50% or greater inspired O2. Although it is expected that most eligible subjects will be receiving positive end-expiratory pressure (PEEP) or CPAP ≥5 cm H2O consistent with the original Berlin definition (ARDS Definition Task Force 2012), these measures will not be mandated as entry criteria.\n- 3. Age ≥18 years\n- 4. Informed consent obtained from subject/next of kin/legal proxy\n- 5. Clear or convincing evidence of a precipitating infection during the 7 days preceding the diagnosis of ARDS in the judgement of the screening or primary care team.\n- 6. During the course of the study starting at screening and for 4 days after the final study treatment, for a total of 10 days: a. Female subjects of childbearing potential must agree to abstinence or use 2 medically accepted and approved birth control methods b. Male subjects with a partner who might become pregnant must agree to use reliable forms of contraception (i.e., vasectomy, abstinence), or an acceptable method of birth control must be used by the partner c. All subjects must agree not to donate sperm or eggs"}

Exclusion criteria

  • {"criterion_text":"- 1. Ongoing evidence or suspicion that heart failure, volume overload, pulmonary emboli, chronic lung disease, pleural effusion, cardiac tamponade, or constrictive pericarditis are materially contributing to the clinical or radiological findings as assessed by the care team or Investigator; an echocardiogram is strongly recommended as part of standard care to exclude a significant contribution of systolic or diastolic heart failure and volume overload.\n- 6. Previous splenectomy\n- 7. Immunosuppressed condition\n- 8. Any vaccination in the previous 30 days\n- 9. Participation in an interventional clinical trial (e.g., device, drug, or biologic) in the previous 30 days or 5 half-lives of the previous medicinal product, if longer\n- 14. Chronic mechanical ventilation or dialysis\n- 15. Unsuitable for study participation, in the opinion of the Investigator, because of chronic, severe, end-stage, or life-limiting underlying disease unrelated to current infection likely to interfere with management and assessment of ARDS, only comfort or limited (non-aggressive) care is to be given, or life expectancy <6 months unrelated to acute infection in the opinion of the Investigator.\n- 10. Known allergy to study drug or excipients\n- 11. Weight >125 kg or <32 kg\n- 12. Active underlying cancer or treatment with systemic chemotherapy or radiation therapy during the last 60 days or likely to require similar treatments during the ensuing 6 months.\n- 13. Transplantation of hematopoietic or solid organs, graft versus host disease, or post-transplant lymphoproliferative disease.\n- 2. Systemic fungal, yeast, or parasitic, or mycobacterial infection\n- 3. Current or planned receipt of extracorporeal membrane oxygenation (ECMO).\n- 4. Pregnant or lactating women.\n- 5. Permanent tracheostomy or chronic ventilatory support"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- All-cause mortality at Day 28 between treatment groups","definition_or_measurement_approach":"Measured as all-cause mortality at Day 28 comparing rhu-pGSN plus SOC versus placebo plus SOC between treatment groups."}

Secondary endpoints

  • {"endpoint_text":"- Efficacy: Ventilator-free days through Day 28 between treatment groups","definition_or_measurement_approach":"Ventilator-free days through Day 28 compared between treatment groups."}
  • {"endpoint_text":"- Efficacy: All-cause mortality at Day 60 between treatment groups","definition_or_measurement_approach":"Measured as all-cause mortality at Day 60 comparing treatment groups."}
  • {"endpoint_text":"- Efficacy: Proportion of surviving subjects without respiratory support at Day 28 between treatment groups","definition_or_measurement_approach":"Proportion of survivors not requiring respiratory support at Day 28 compared between treatment groups."}
  • {"endpoint_text":"- Efficacy: Time to death and proportions of subjects dying over time (Days 7, 14, and 28) between treatment groups","definition_or_measurement_approach":"Time-to-event analysis for death and proportions dying at Days 7, 14, and 28 between groups."}
  • {"endpoint_text":"- Efficacy: Proportion of surviving subjects without respiratory support over time (Days 7, 14, and 28) between treatment groups","definition_or_measurement_approach":"Proportions of survivors without respiratory support at Days 7, 14 and 28 compared between groups."}
  • {"endpoint_text":"- Efficacy: Time to discontinuation of respiratory support and proportions without respiratory support over time (Days 7, 14, and 28) between treatment groups","definition_or_measurement_approach":"Time to discontinuation of respiratory support and proportions without support at Days 7, 14, 28 compared between groups."}
  • {"endpoint_text":"- Efficacy: For subjects not intubated at entry, the frequency of intubation through Day 28 between treatment groups","definition_or_measurement_approach":"Frequency (incidence) of intubation through Day 28 among subjects not intubated at baseline compared between groups."}
  • {"endpoint_text":"- Efficacy: To evaluate the days in the ICU and in the hospital through Day 28 between treatment groups","definition_or_measurement_approach":"Number of ICU days and hospital days through Day 28 compared between treatment groups."}
  • {"endpoint_text":"- Efficacy: Frequency of RRT through Day 28 between treatment groups","definition_or_measurement_approach":"Frequency of renal replacement therapy (RRT) use through Day 28 compared between groups."}
  • {"endpoint_text":"- Safety: Incidence, causality, and severity of SAEs and AEs (graded according to the NCI CTCAE version 5.0 [or higher]) in rhu-pGSN vs placebo groups","definition_or_measurement_approach":"Incidence, causality and severity of SAEs and AEs assessed and graded per NCI CTCAE v5.0 (or higher) comparing groups."}
  • {"endpoint_text":"- Safety: New or worsening clinically significant laboratory abnormalities in rhu-pGSN vs placebo groups","definition_or_measurement_approach":"Incidence of new or worsening clinically significant laboratory abnormalities compared between groups."}

Recruitment

Planned Sample Size
228
Recruitment Window Months
24
Consent Approach
Informed consent is obtained from the subject or from next of kin/legal proxy where appropriate. Country-specific subject information sheets and ICFs and legal representative/trusted person forms are provided (examples in the document set: country-specific ICFs and legal representative/Trusted Person forms such as L1_Spouse and LR ICF_DE, L1_Recovered Capacity ICF_DE, L1_FR_ICF_Trusted Person_fr, L1_NL_Legal Representative_SIS ICF). Documents include pregnancy follow-up ICFs and translated ICFs for local languages.

Geography

Total Number Of Sites
54
Total Number Of Participants
372

Hungary

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
544
Number Of Sites
8
Number Of Participants
60

Sites

Site Name
Szent Damjan Goeroegkatolikus Korhaz
Department Name
Aneszteziológiai és Intenzív Terápiás Osztály
Principal Investigator Name
Norbert Erdélyi
Principal Investigator Email
titkarsag@kisvardakorhaz.hu
Contact Person Name
Norbert Erdélyi
Contact Person Email
titkarsag@kisvardakorhaz.hu
Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Központi Aneszteziológiai és Intenzív Terápiás Osztály
Principal Investigator Name
Csaba Hermann
Principal Investigator Email
indrhecs@gmail.com
Contact Person Name
Csaba Hermann
Contact Person Email
indrhecs@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Aneszteziológiai és Intenzív Terápiás Osztály
Principal Investigator Name
Attila Szűcs
Principal Investigator Email
dr.szucs.attila@szszbmk.hu
Contact Person Name
Attila Szűcs
Contact Person Email
dr.szucs.attila@szszbmk.hu
Site Name
Veszprem Varmegyei Csolnoky Ferenc Korhaz
Department Name
Központi Aneszteziológiai és Intenzív Terápiás Osztály
Principal Investigator Name
Béla Gál
Principal Investigator Email
gal.bela@vmkorhaz.hu
Contact Person Name
Béla Gál
Contact Person Email
gal.bela@vmkorhaz.hu
Site Name
Siofoki Korhaz-Rendelointezet
Department Name
Központi aneszteziológiai és intenzív betegellátó osztály
Principal Investigator Name
Ágnes Seer
Principal Investigator Email
info@siokorhaz.hu
Contact Person Name
Ágnes Seer
Contact Person Email
info@siokorhaz.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Központi aneszteziológiai és intenzív betegellátó osztály
Principal Investigator Name
Ágnes Sárkány
Principal Investigator Email
asarkany1@gmail.com
Contact Person Name
Ágnes Sárkány
Contact Person Email
asarkany1@gmail.com
Site Name
Koranyi National Institute For Pulmonology
Department Name
Központi Anaestheziológiai és Intenzív Terápiás Osztály
Principal Investigator Name
Szabolcs Szigeti
Principal Investigator Email
szigeti.szabolcs@koranyi.hu
Contact Person Name
Szabolcs Szigeti
Contact Person Email
szigeti.szabolcs@koranyi.hu
Site Name
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Department Name
Központi Aneszteziológiai és Intenzív Betegellátó Osztály
Principal Investigator Name
Péter Németh
Principal Investigator Email
peternemeth.mail@gmail.com
Contact Person Name
Péter Németh
Contact Person Email
peternemeth.mail@gmail.com

Romania

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
545
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
Department Name
Emergency, intensive care
Principal Investigator Name
Ovidiu Bedreag
Principal Investigator Email
ovidiu.bedreag@yahoo.com
Contact Person Name
Ovidiu Bedreag
Contact Person Email
ovidiu.bedreag@yahoo.com
Site Name
Spitalul Clinic Judetean Mures
Department Name
Emergency, intensive care
Principal Investigator Name
Mircea Stoian
Principal Investigator Email
mircea.stoian@umfst.ro
Contact Person Name
Mircea Stoian
Contact Person Email
mircea.stoian@umfst.ro
Site Name
Elias University Emergency Hospital
Department Name
Emergency, intensive care
Principal Investigator Name
Silvius Negoita
Principal Investigator Email
silviusneg@gmail.com
Contact Person Name
Silvius Negoita
Contact Person Email
silviusneg@gmail.com
Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Emergency, intensive care
Principal Investigator Name
Andreea Monica Birjaru
Principal Investigator Email
andreea.birjaru@gmail.com
Contact Person Name
Andreea Monica Birjaru
Contact Person Email
andreea.birjaru@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
530
Number Of Sites
4
Number Of Participants
32

Sites

Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Intensive care medicine and anesthesiology
Principal Investigator Name
Chavdar Stefanov
Principal Investigator Email
prof.chavdar.stefanov@gmail.com
Contact Person Name
Chavdar Stefanov
Site Name
Tokuda Hospital
Department Name
Anesthesiology
Principal Investigator Name
Nikolay Mladenov
Principal Investigator Email
nikodoc@abv.bg
Contact Person Name
Nikolay Mladenov
Contact Person Email
nikodoc@abv.bg
Site Name
Military Medical Academy
Department Name
"Intensive treatment" clinic, part of "Trauma-center"
Principal Investigator Name
Nikolay Petrov
Principal Investigator Email
niki.petrov@abv.bg
Contact Person Name
Nikolay Petrov
Contact Person Email
niki.petrov@abv.bg
Site Name
Alexandrovska University Hospital
Department Name
Intensive care medicine and anesthesiology
Principal Investigator Name
Yordanka Yamakova
Principal Investigator Email
y_yamakova@hotmail.com
Contact Person Name
Yordanka Yamakova
Contact Person Email
y_yamakova@hotmail.com

Germany

Earliest CTIS Part Ii Submission Date
21-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
541
Number Of Sites
4
Number Of Participants
24

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Anaestegiology and intensive care medicine
Principal Investigator Name
Claudia Spies
Principal Investigator Email
claudia.spies@charite.de
Contact Person Name
Claudia Spies
Contact Person Email
claudia.spies@charite.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
Anaesthesiology
Principal Investigator Name
Johannes Ehler
Principal Investigator Email
johannes.ehler@med.uni-jena.de
Contact Person Name
Johannes Ehler
Contact Person Email
johannes.ehler@med.uni-jena.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Anaesthesiology
Principal Investigator Name
Andreas Meiser
Principal Investigator Email
Andreas.Meiser@uks.eu
Contact Person Name
Andreas Meiser
Contact Person Email
Andreas.Meiser@uks.eu
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Anaesthesiology
Principal Investigator Name
Sandra Frank
Principal Investigator Email
Sandra.Frank@med.uni-muenchen.de
Contact Person Name
Sandra Frank

Italy

Earliest CTIS Part Ii Submission Date
22-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
540
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Azienda Ospedaliera Dei Colli
Department Name
UOC Fisiopatologia e riabilitazione respiratoria
Principal Investigator Name
Giuseppe Fiorentino
Principal Investigator Email
giuseppe.fiorentino@ospedalideicolli.it
Contact Person Name
Giuseppe Fiorentino
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa di Anestesia Rianimazione, Terapia Intensiva e Tossicologia Clinica
Principal Investigator Name
Domenico Luca Grieco
Principal Investigator Email
domenicoluca.grieco@policlinicogemelli.it
Contact Person Name
Domenico Luca Grieco
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Department of Emergency
Principal Investigator Name
Michele Bertoni
Principal Investigator Email
bertoni.mc@gmail.com
Contact Person Name
Michele Bertoni
Contact Person Email
bertoni.mc@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
23-10-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
538
Number Of Sites
6
Number Of Participants
45

Sites

Site Name
Gelre Hospitals
Department Name
Intensive Care
Principal Investigator Name
Peter E. Spronk
Principal Investigator Email
p.spronk@gelre.nl
Contact Person Name
Peter E. Spronk
Contact Person Email
p.spronk@gelre.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Intensive Care
Principal Investigator Name
Koen Simons
Principal Investigator Email
k.simons@jbz.nl
Contact Person Name
Koen Simons
Contact Person Email
k.simons@jbz.nl
Site Name
Ziekenhuis Gelderse Vallei Stichting
Department Name
Intensive Care Unit
Principal Investigator Name
Arthur R.H. van Zanten
Principal Investigator Email
ZantenA@zgv.nl
Contact Person Name
Arthur R.H. van Zanten
Contact Person Email
ZantenA@zgv.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Intensive Care
Principal Investigator Name
Peter Pickkers
Principal Investigator Email
peter.pickkers@radboudumc.nl
Contact Person Name
Peter Pickkers
Contact Person Email
peter.pickkers@radboudumc.nl
Site Name
Medisch Spectrum Twente
Department Name
Intensive Care Centrum
Principal Investigator Name
Albertus Beishuizen
Principal Investigator Email
B.beishuizen@mst.nl
Contact Person Name
Albertus Beishuizen
Contact Person Email
B.beishuizen@mst.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Department Name
ICU, B44
Principal Investigator Name
Oscar Hoiting
Principal Investigator Email
o.hoiting@cwz.nl
Contact Person Name
Oscar Hoiting
Contact Person Email
o.hoiting@cwz.nl

Spain

Earliest CTIS Part Ii Submission Date
21-10-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
543
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
Intensive Care
Principal Investigator Name
Alejandro Rodriguez Oviedo
Principal Investigator Email
ahr1161@yahoo.es
Contact Person Name
Alejandro Rodriguez Oviedo
Contact Person Email
ahr1161@yahoo.es
Site Name
Hospital Universitario De Getafe
Department Name
Intensive Care
Principal Investigator Name
Jose Lorente
Principal Investigator Email
joseangel.lorente@salud.madrid.org
Contact Person Name
Jose Lorente
Site Name
Salut Sant Joan De Reus
Department Name
Intensive care medicine
Principal Investigator Name
Juan Antonio Brito Piris
Principal Investigator Email
britopiris@gmail.com
Contact Person Name
Juan Antonio Brito Piris
Contact Person Email
britopiris@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Intensive Care
Principal Investigator Name
Pedro Carstro Rebollo
Principal Investigator Email
pcastro@clinic.cat
Contact Person Name
Pedro Carstro Rebollo
Contact Person Email
pcastro@clinic.cat
Site Name
Hospital Clinico San Carlos
Department Name
Intensive Care
Principal Investigator Name
Fernando Martinez Sagasti
Principal Investigator Email
fmarsagasti@gmail.com
Contact Person Name
Fernando Martinez Sagasti
Contact Person Email
fmarsagasti@gmail.com
Site Name
Bellvitge University Hospital
Department Name
Intensive Care
Principal Investigator Name
Oriol Roca
Principal Investigator Email
oriol.roca@bellvitgehospital.cat
Contact Person Name
Oriol Roca
Site Name
Hospital Universitario 12 De Octubre
Department Name
Intensive Care
Principal Investigator Name
Mario Chico Fernandez
Principal Investigator Email
Murgchico@yahoo.es
Contact Person Name
Mario Chico Fernandez
Contact Person Email
Murgchico@yahoo.es
Site Name
Parc Tauli Hospital Universitari
Department Name
Intensive care medicine
Principal Investigator Name
Candelaria de Haro López
Principal Investigator Email
cdeharo@tauli.cat
Contact Person Name
Candelaria de Haro López
Contact Person Email
cdeharo@tauli.cat

Czechia

Earliest CTIS Part Ii Submission Date
13-10-2024
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
550
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Department of Anesthesiology and Intensive Care
Principal Investigator Name
Michal Otahal
Principal Investigator Email
michal.otahal@vfn.cz
Contact Person Name
Michal Otahal
Contact Person Email
michal.otahal@vfn.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Anesthesiology and Resuscitation Clinic
Principal Investigator Name
Frantisek Duska
Principal Investigator Email
fduska@yahoo.com
Contact Person Name
Frantisek Duska
Contact Person Email
fduska@yahoo.com
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Anesthesiology and Resuscitation Clinic
Principal Investigator Name
Pavel Suk
Principal Investigator Email
pavel.suk@fnusa.cz
Contact Person Name
Pavel Suk
Contact Person Email
pavel.suk@fnusa.cz
Site Name
Krajska nemocnice Liberec a.s.
Department Name
Center of Anesthesiology, Resuscitation and Intensive Medicine
Principal Investigator Name
Pavel Sedlak
Principal Investigator Email
pavel.sedlak@nemlib.cz
Contact Person Name
Pavel Sedlak
Contact Person Email
pavel.sedlak@nemlib.cz

France

Earliest CTIS Part Ii Submission Date
06-11-2024
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
527
Number Of Sites
8
Number Of Participants
60

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Medical Intensive Care Unit
Principal Investigator Name
Alexandre Demoule
Principal Investigator Email
alexandre.demoule@aphp.fr
Contact Person Name
Alexandre Demoule
Contact Person Email
alexandre.demoule@aphp.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Vendee
Principal Investigator Name
Jean-Claude Lacherade
Principal Investigator Email
jean-claude.lacherade@ght85.fr
Contact Person Name
Jean-Claude Lacherade
Contact Person Email
jean-claude.lacherade@ght85.fr
Site Name
Hospices Civils De Lyon
Department Name
Soins critiques
Principal Investigator Name
Bernard Allaouchiche
Principal Investigator Email
bernard.allaouchiche@chu-lyon.fr
Contact Person Name
Bernard Allaouchiche
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service de Médecine Intensive - Réanimation
Principal Investigator Name
Julie Helms
Principal Investigator Email
julie.helms@chru-strasbourg.fr
Contact Person Name
Julie Helms
Contact Person Email
julie.helms@chru-strasbourg.fr
Site Name
Bicetre Hospital
Department Name
Médecine intensive réanimation
Principal Investigator Name
Tai Pham
Principal Investigator Email
tai.pham@aphp.fr
Contact Person Name
Tai Pham
Contact Person Email
tai.pham@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Médecine intensive réanimation
Principal Investigator Name
Jean-Baptiste Lascarrou
Principal Investigator Email
jeanbaptiste.lascarrou@chu-nantes.fr
Contact Person Name
Jean-Baptiste Lascarrou
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Médecine intensive et réanimation
Principal Investigator Name
Muriel Fartoukh
Principal Investigator Email
muriel.fartoukh@aphp.fr
Contact Person Name
Muriel Fartoukh
Contact Person Email
muriel.fartoukh@aphp.fr
Site Name
Groupe Hospitalier Du Sud Ile De France
Department Name
Intensive care medicine
Principal Investigator Name
Mehran Monchi
Principal Investigator Email
mehran.monchi@ghsif.fr
Contact Person Name
Mehran Monchi
Contact Person Email
mehran.monchi@ghsif.fr

Belgium

Earliest CTIS Part Ii Submission Date
21-10-2024
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
541
Number Of Sites
5
Number Of Participants
38

Sites

Site Name
Clinique Saint-Pierre
Department Name
Intensive Care Unit
Principal Investigator Name
Nicolas De Schryver
Principal Investigator Email
nicolas.deschryver@cspo.be
Contact Person Name
Nicolas De Schryver
Contact Person Email
nicolas.deschryver@cspo.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Intensive Care Unit
Principal Investigator Name
Bernard Lambermont
Principal Investigator Email
b.lambermont@chuliege.be
Contact Person Name
Bernard Lambermont
Contact Person Email
b.lambermont@chuliege.be
Site Name
Hopital Erasme
Department Name
Intensive Care Unit
Principal Investigator Name
Fabio Taccone
Principal Investigator Email
fabio.taccone@hubruxelles.be
Contact Person Name
Fabio Taccone
Contact Person Email
fabio.taccone@hubruxelles.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Intensive Care Unit
Principal Investigator Name
Vincent Fraipont
Principal Investigator Email
vincent.fraipont@citadelle.be
Contact Person Name
Vincent Fraipont
Contact Person Email
vincent.fraipont@citadelle.be
Site Name
HUmani
Department Name
Intensive Care Unit
Principal Investigator Name
Michaël Piagnerelli
Principal Investigator Email
michael.piagnerelli@humani.be
Contact Person Name
Michaël Piagnerelli
Contact Person Email
michael.piagnerelli@humani.be

Sponsor

Primary sponsor

Full Name
Bioaegis Therapeutics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Ergomed Clinical Research Limited
Responsibilities
[1,10,12,13,2,3,5,6,7,9]
Name
Kcas LLC
Responsibilities
[4]
Name
Primevigilance Limited
Responsibilities
[8]
Name
Medicover Integrated Clinical Services Sp. z o.o.
Responsibilities
[4]
Name
Rxsource Limited
Responsibilities
[14]

Third parties

  • {"country":"United States","full_name":"Kcas LLC","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"[8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Ergomed Clinical Research Limited","duties_or_roles":"[1,10,12,13,2,3,5,6,7,9]","organisation_type":"Pharmaceutical company"}
  • {"country":"Poland","full_name":"Medicover Integrated Clinical Services Sp. z o.o.","duties_or_roles":"[4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Ireland","full_name":"Rxsource Limited","duties_or_roles":"[14]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
RECOMBINANT HUMAN PLASMA GELSOLIN
Active Substance
HUMAN PLASMA GELSOLIN, RECOMBINANT
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
MIA number IMP12968/00001 (investigational product)
Frequency
6 doses (schedule not specified)
Maximum Dose
24 mg/kg per day; maximum total 84 mg/kg
Investigational Product Name
Placebo, 0.9% saline solution
Modality
Other
Combination Treatment
Yes

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