Clinical trial · Observational
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
NCT04635111CI-TRIAL-00096335recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatotoxicity | — | UNRESOLVED | — |
| Tenosynovial Giant Cell Tumor | Tenosynovial Giant Cell Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TURALIO™ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Symptomatic TGCT Participants
- description
- Adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience moderate or severe hepatotoxicity due to use of TURALIO™ (pexidartinib).
- interventionNames
- Drug: TURALIO™
Primary outcomes (1)
- measure
- Frequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib)
- timeFrame
- Baseline up to 10 years
- description
- Hepatic failure is defined as severe liver injury with encephalopathy and impaired synthetic function (INR \>= 1.5) as well as liver transplant and hepatic-related death.
Secondary outcomes (3)
- measure
- Number of Participants With Liver Test Abnormalities
- timeFrame
- Baseline up to 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.