PHASE II CLINICAL STUDY ON THE USE OF HCV+ DONORS FOR SOLID ORGAN TRANSPLANTATION.

Phase 1

• Conditions: MedDRA version: 20.0Level: PTClassification code 10024714Term: Liver transplantSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: PTClassification code 10063837Term: Reperfusion injurySystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 20.1Level: PTClassification code 10058060Term: Graft complicationSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; SE OF POSITIVE DONORS FOR INFECTION OF THE HEPATITIS VIRUS FOR THE TRANSPLANTATION OF SOLID ORGANS IN AN ENDEMIC AREA FOR HEPATITIS C WITH LOW RATE OF DONATIONS FROM CADAVERS: OPEN PHASE II CLINICAL STUDY.; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-003640-23-IT
• Lead Sponsor: ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE - ISMETT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-22
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

1) male or female recipient over 18 years of age.
2) negative candidate for HCV candidate and inserted in waiting list for solid organ transplant at IRCCS / ISMETT.
3) Female recipients potentially able to undertake a pregnancy who have committed themselves to ensure an effective practice of birth control during the first 6 months of study.
4) recipient affected by a terminal stage disease or oncological pathology, suitable candidate and included in waiting list for organ transplantation at IRCCS / ISMETT.
5) a patient who understands the purpose and risks of the study, who has been fully informed and has given written informed consent.
6) a patient unable to write and / or read, but who is fully capable of understanding the oral information proposed by the researcher (or the appointed representative) and who has given oral informed consent written in written form by an independent third person .
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

1) patients with acute organ failure
2) pediatric patients or pediatric donor solid organ transplant candidates
3) patient in poor multi-organ clinical conditions
4) patient candidate for multi-organ transplantation
5) participant or who has participated in another clinical trial and / or who is taking or has taken an experimental drug in the last 30 days
6) patient with absolute improbability to respect the programmatic visits foreseen by the protocol
7) patient with any form of substance abuse, and / or carrier of psychiatric disorders or a condition that, in the opinion of the investigator, can invalidate the communication with the researcher himself.
8) patient over the age of 70.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified