Domestic Safety Information Survey on Immunosuppressive Therapy in Living Liver Transplant

JRCT ID: jRCT1050210062

Registered date:13/08/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with end-stage liver disease suitable for liver transplantation and their liver donors
• Date of first enrollment: 07/03/2022
• Target sample size: 50
• Study type: Observational

Outcome(s)

Primary Outcome

1) Serious adverse events from the date of liver transplantation to the time of final observation
2) Serious side effects from the date of liver transplantation to the time of final observation
3) Immunosuppressant-related side effects of particular note from the date of liver transplantation to the time of final observation
etc.

Secondary Outcome

1) Incidence rate of rejection after transplantation
2) Incidence of no rejection
3) Patient survival rate
etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

(1) Patients who have given written informed consent to participate in the clinical trial.
(2) Male or Female patients aged between 20 and 80 years old at the time of obtaining informed consent.
(3) Patients who have been approved or will be approved for living-donor liver transplantation at the Medical Ethics Committee or equivalent organization established by the institution.
(4) Patients who have not used the investigational drug, device or product within 3 months of obtaining consent.(recipient)
(5) Patients who have not previously used JB-101 and do not plan to use it during the study subject observation period.(recipient)
(6) Patients who are judged by principal investigators or sub-investigators, to be able to carry out the observation for the period specified in this research, based on the place of residence, etc.

• Exclude criteria: -

Related Information

• Primary Sponsor: Uchida Koichiro
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,JUNTEN BIO Co.,Ltd.