A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon optional liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.
Eligibility criteria
Qualifiers
Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
Age ≥18 years old
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) >2 × ULN
Isolated TBIL >2 × ULN (excluding patients with Gilbert's syndrome)
Disqualifiers
Not applicable
Trial design
Treatments tested in this trial
- TURALIO™
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov