NCT04635111 A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
| NCT ID | NCT04635111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Daiichi Sankyo |
| Condition | Hepatotoxicity |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-01-07 |
| Primary Completion | 2036-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2021-01-07 with a primary completion date of 2036-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Global Clinical Leader
STUDY DIRECTOR
Daiichi Sankyo
Frequently Asked Questions
Who can join the NCT04635111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatotoxicity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04635111 currently recruiting?
Yes, NCT04635111 is actively recruiting participants. Contact the research team at CTRinfo@dsi.com for enrollment information.
Where is the NCT04635111 trial being conducted?
This trial is being conducted at Santa Monica, United States, Santa Monica, United States, Santa Monica, United States, Whittier, United States and 4 additional locations.
Who is sponsoring the NCT04635111 clinical trial?
NCT04635111 is sponsored by Daiichi Sankyo. The principal investigator is Global Clinical Leader at Daiichi Sankyo. The trial plans to enroll 30 participants.