This study is looking at whether children who have had a liver transplant can safely reduce their dose of tacrolimus, a medicine that prevents the body from rejecting the new organ. Researchers want to see if reducing tacrolimus by 50% in two steps is successful. The study will include 100 children between 3 and 13 years old who received a liver transplant when they were under 7 years old and are now 3 to 7 years post-transplant. The main goal is to see if this reduction is successful after 18 months.

Study design

This is an interventional study involving 100 participants. It is a multi-center, longitudinal study, meaning it follows participants over time at different locations.

What's involved

You would reduce your tacrolimus dose in two steps. You would have liver tests every 0.5 months for the first 4 months, then monthly until month 12, and every other month until month 18. You would also have clinic visits at screening, 6, 12, and 18 months, and a liver biopsy at 18 months.

Compensation

Not stated in the trial record.

Follow-up

The primary endpoint is assessed at 18 months after starting the dose reduction.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.