Ensayos clínicos

Donation after Brain Death (DBD) Liver Inclusion Criteria (one or more):

- Donor age 50-85 years

- Anticipated cold ischemia time 10-15 hours (excluding HOPE duration)

- Macrosteatosis 10-40%

- Terminal ALT 250-1500 IU/ml

- Peak ALT within 3 days 1000-3000 IU/ml

- Terminal total bilirubin 2-4 mg/dl

Donation after Brain Death (DBD) Liver Exclusion Criteria (one or more):

- Donor age <18 or >85 years

- Anticipated cold ischemia >15 hours

- Macrosteatosis >40%

- Terminal ALT >1500 IU/ml

- Peak ALT within 3 days >3000 IU/ml

- Terminal total bilirubin >4 mg/dl

- Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of
the Investigator, make the liver allograft unsuitable for transplant into the
recipient subject

- Liver intended for split transplant

- Liver from living donor

- Donor terminal serum Na >160 mmol/L

Donation after Cardio-circulatory Death (DCD) Liver Inclusion Criteria (all):

- Donor age 18-60 years

- Anticipated cold ischemia time <12 hours (excluding HOPE duration)

- Functional warm ischemia time ≤35 minutes, defined as interval from the time of onset
of donor hypotension (MAP <50mmHg) until the time of donor cross clamp

- Macrosteatosis ≤20%

- Terminal ALT ≤500 IU/ml

- Peak ALT within 3 days ≤2000 IU/ml

- Terminal total bilirubin ≤3 mg/dl

Donation after Cardio-circulatory Death (DCD) Liver Exclusion Criteria (one or more):

- Presence of hemodynamic and/or anatomical donor abnormalities that, in the opinion of
the Investigator, make the liver allograft unsuitable for transplant into the
recipient subject

- Liver intended for split transplant

- Liver from living donor

- Donor terminal serum Na >160 mmol/L

Recipient Inclusion Criteria (one or more):

- Subject (or legally authorized representative) is able to provide informed consent and
HIPAA authorization

- Subject is male or female and at least 18 years of age

- Subject is registered as an active liver recipient on the UNOS waiting list for liver
transplantation

- Subject will undergo primary liver transplantation

- Subject is willing to comply with the study requirements and procedures

- Subject with hepatocellular carcinoma as indication for Orthotopic Liver
Transplantation; the tumor must be within Milan Criteria or down-staged to Milan
Criteria

Recipient Exclusion Criteria (one or more):

- Subject will undergo multiple organ transplantations (liver-kidney, liver-lung, etc.)

- Subject is listed for liver transplantation due to fulminant liver failure (UNOS
status 1A)

- Subject is pregnant

- Subject is on respiratory (ventilator dependent) and/or cardiocirculatory support
(requires at least one intravenous inotrope to maintain hemodynamics)

- Subject is enrolled in an interventional clinical trial with an investigational drug
or device

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.