Clinical Trials

Inclusion Criteria:

• Adult patients 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 below liver test abnormalities, during or following TURALIO exposure, that does not have a clear alternative cause (e.g., acute viral hepatitis A infection):
  • AST or ALT > 3 × ULN with concurrent total bilirubin > 2 × ULN;
  • Isolated total bilirubin > 2 × ULN (excluding patients with Gilbert’s syndrome);
  • Isolated AST or ALT > 10 × ULN;
  • ALP > 2 × ULN with GGT > 2 × ULN;
  • A minimum of 5 patients for each of the first, third, and fourth laboratory abnormality patterns will be enrolled into the study.
    • Note: some or all of the patients who meet the fourth abnormality category may also meet the first and/or third categories).
• Consent to study procedures, long-term safety follow-up, and use of patient data from the TURALIO REMS program.

Exclusion Criteria:

• None.