Prospective, Multicenter Clinical Study of Prolonged-release Tacrolimus in Stable Pediatric Liver Transplant Recipients

Launched by RENJI HOSPITAL · Dec 27, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how well a new form of medication called prolonged-release tacrolimus works for children who have received a liver transplant. The study aims to find out if these capsules can help reduce the chances of acute rejection of the liver and slow down liver damage, which is also known as fibrosis. The trial is currently looking for participants, specifically children up to 18 years old, who have been stable after their liver transplant and have been taking a different form of tacrolimus for at least three months.

To be eligible for this study, children must be able to swallow capsules and have normal blood and organ functions. They will also need to have a scheduled liver biopsy, which is a procedure to check the health of the liver. However, children who have had multiple organ transplants or are allergic to tacrolimus cannot participate. If your child is chosen for the trial, they will take the new medication and be closely monitored by the researchers to see how it affects their health. This study is an important step in finding better treatments for children with liver transplants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Children (≤18 years old) who have undergone liver transplantation, with no gender limitations;
• • 2. Able to completely swallow capsules;
• • 3. Have been using immediate-release tacrolimus for at least three months prior to study enrollment;
• • 4. Have normal blood count, liver and kidney function, coagulation function, and considered clinically stable by researchers;
• • 5. Undergo a programmed liver biopsy;
• Exclusion Criteria:
• • 1. Multi-organ combined transplantation or multiple liver transplantation;
• • 2. Adjuvant liver transplantation or use of bioartificial liver therapy;
• • 3. ABO incompatible children with liver transplantation;
• • 4. Allergic to tacrolimus;
• • 5. Participation in any other clinical study within 3 months prior to enrollment;
• • 6. Use of tacrolimus sustained release capsules before enrollment;
• • 7. Tacrolimus trough concentration lower than 3.5 ng/ml at the time of screening;