A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
Sponsored by Daiichi Sankyo, Inc.
About this trial
Last updated 2 years ago
Study ID
PL3397-A-U401
Status
Recruiting
Type
Observational [Patient Registry]
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 5 years ago
What is this trial about?
A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and
the mechanism of liver injury based upon liver biopsy information among patients who received
or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.
What are the participation requirements?
Inclusion Criteria
- Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery
- Age ≥18 years old
- Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:
- 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)
- Isolated AST or ALT >10 × ULN
- Alkaline phosphatase (ALP) >2 x ULN with gamma-glutamyl transferase (GGT) >2 x ULN
- Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program
Exclusion Criteria
- Not applicable