NEurotrophins MImetic compound for modulation of ischemia/reperfusion damage in Liver transplantation with Extended criteria Donors, a phase I/II explorative, open label, controlled, randomized study

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites · Protocol NEMILED

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Authorised, recruitment pending

Participants planned 24

Countries 1

Sites 1

Liver Transplant

Key facts

Sponsor: Mimetech S.r.l.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]
Decision date (initial): 2024-03-13
Transition trial: No
Low-intervention: No
Rare-disease indication: Yes
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Liver Transplant

Version	Level	Code	Term	System organ class
20.0	PT	10024714	Liver transplant	100000004865

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Mimetech S.r.l.

Sponsor organisation: Mimetech S.r.l.
Address: Via Della Cernaia 21
City: Florence
Postcode: 50129
Country: Italy

Scientific contact point

Organisation: Mimetech S.r.l.
Contact name: Federico Cozzolino

Public contact point

Organisation: Mimetech S.r.l.
Contact name: Federico Cozzolino

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Italy	Authorised, recruitment pending	24	1
Rest of world	—	0	—

Investigational sites

Italy

1 site · Authorised, recruitment pending

IRCCS Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi

Department of Medical and Surgical Sciences, Via Massarenti 9, 40138, Bologna

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2023-11-07	Italy	Acceptable 2024-03-11	2024-03-13
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-08-04	Italy	Acceptable 2024-03-11	2025-08-04