Long-term Study of Liver Safety and Hepatotoxicity in Adults Taking TURALIO Pexidartinib for Tenosynovial Giant Cell Tumor

What this Trial Is About

Researchers are studying the long-term risk of liver failure linked to TURALIO14 pexidartinib treatment in patients with symptomatic tenosynovial giant cell tumor TGCT who have severe symptoms or functional problems and cannot improve with surgery. This study also explores how liver damage happens by examining liver biopsy samples from patients who have or had liver toxicity while on TURALIO14. The goal is to understand liver injury mechanisms and assess safety over time. This is a non-interventional, observational study where no study medication is given. Participants have experienced liver test abnormalities from TURALIO14 treatment. Optional liver biopsies will be taken for detailed analysis of immune cells in the liver. Blood samples will also be collected to monitor liver function, safety, immune cells, and genetics. Participants will be followed yearly for up to 10 years to track liver health and potential failure after stopping TURALIO14. During the study, participants will provide blood samples and may choose to have a liver biopsy for further testing. Researchers will assess liver test results and monitor for signs of liver failure, liver transplant need, or death. Follow-up visits occur at least once per year for 10 years to observe long-term effects. The main outcome measured is how often liver failure occurs after stopping TURALIO14, helping to better understand long-term safety in this group.

A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment