USE 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. MedDRA version: 20.0 Level: PT Classification code 10024714 Term: Liver transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10063837 Term: Reperfusion injury System Organ Class: 10047065 - Vascular disorders MedDRA v
Conditions
Interventions
Trade Name: EPCLUSA
Product Name: EPCLUSA SOFOSBUVIR 400MG/VELPATASVIR 100MG
Product Code: [1BV30D]
Pharmaceutical Form: Film-coated tablet
CAS Number: 1190307-88-0
Current Sponsor code: GS-7977
Conce
Sponsors
ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE - ISMETT
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Single-center, open, phase II prospective study designed to evaluate the non-inferiority of the efficacy of HCV antiviral treatment in HCV-negative patients receiving a solid organ transplant (liver, kidney, heart, lung and pancreas) from positive donors for Hepatitis C virus (DONORHCV +).;Secondary Objective: - average annual number of organs, from HCV + donors, used for solid organ transplantation (liver, kidney, heart, lung, pancreas); - absence of HCV infection (HCV-RNA negativity) 24 weeks after the completetion of antiviral treatment; - adverse events of the drug; - 12-month survival of the transplanted organ; - absence of HCV (HCV-RNA negative) infection 48 weeks after the end of the antiviral treatment cycle (SVR48); - 1-year survival of the transplanted organ; - 5-year survival of the transplanted organ.;Primary end point(s): Absence of HCV infection (negative HCV-RNA) at 12-weeks after completation of the cycle of antiviral treatment.;Timepoint(s) of evaluation of this end point: 12 weeks after the 12-week antiviral treatment cycle has been discontinued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): average annual number of organs, from HCV + donors, used for solid organ transplantation (liver, kidney, heart, lung, pancreas);; absence of HCV infection (negative HCV-RNA) at 24 and 48 weeks after completion of the cycle of antiviral treatment; adverse events of the drug;; 12-month and 5 years survival of the transplanted organ.;Timepoint(s) of evaluation of this end point: for the duration of the study; 24 and 48 weeks after the 12-week antiviral treatment cycle has been discontinued; For the duration of the study; 12 months and 5 years after transplantation | — |
Countries
European Union, Italy
Contacts
Public ContactFARMACIA
ISTITUTO MEDITERRANEO PER I TRAPIANTI AD ALTA SPECIALIZZAZIONE - ISMETT
Outcome results
None listed