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NCT04635111 · ClinicalTrials.gov registry record
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
A clinical trial of Tenosynovial Giant Cell Tumor and Hepatotoxicity, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- 30
- Enrollment target
- 8
- Study locations
NCT04635111: Recruiting study of Tenosynovial Giant Cell Tumor and Hepatotoxicity, sponsored by Daiichi Sankyo.
NCT04635111 is a study of Tenosynovial Giant Cell Tumor and Hepatotoxicity that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 30 participants, below the 114-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04635111, a study of Tenosynovial Giant Cell Tumor and Hepatotoxicity, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG TURALIO™
Study Locations (8)
California
- Kamalesh K Sankhala MD INC - Santa Monica
- Sarcoma Oncology Research Center LLC - Santa Monica
- UCLA Hematology and Oncology - Santa Monica
- The Oncology Institute of Hope and Innovation - Whittier
Massachusetts
- Dana-Farber Cancer Institute - Boston
New York
- Montefiore Medical Center - New York
Ohio
- OSU - James Comprehensive Cancer Center - Columbus
Texas
- Kelsey Seybold Clinic - Pearland - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2036-06-01 |
What NCT04635111 shows while recruiting
NCT04635111 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 114-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 1 intervention - of which TURALIO™ is the first listed.
NCT04635111 lists 8 locations in 5 states (California, Massachusetts, New York).
Frequently Asked Questions
What is clinical trial NCT04635111 about?
NCT04635111 is a clinical study titled "A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment". 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.
What is the current status of trial NCT04635111?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2021-01-07. Estimated completion is 2036-06-01.
What conditions does trial NCT04635111 study?
This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Hepatotoxicity.
What interventions are being tested in trial NCT04635111?
The interventions under investigation include: TURALIO™ (DRUG).
Who is sponsoring clinical trial NCT04635111?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04635111 being conducted?
This trial has 8 study locations across California, Massachusetts, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tenosynovial Giant Cell Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04635111's enrollment target sits among peer trials
30 8th of 8 higher than 1 of 8 other Tenosynovial Giant Cell Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tenosynovial Giant Cell Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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