Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
Approved for marketing
Wellstat Therapeutics
1969-12-31
The purpose of this study is to provide emergency treatment of adult and pediatric patients:
- Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms
or
- Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or
central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g.,
gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of
fluorouracil or capecitabine administration.
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
Completed
Wellstat Therapeutics
Phase 3
2014-04-01
This protocol has two parts - the Main Study which is 42 days in length and the Treatment
Extension which allows the patients who complete the Main Study to continue receiving
treatment with uridine triacetate. The purpose of this study is to replace oral
administration of uridine with oral administration of uridine triacetate in patients with
hereditary orotic aciduria who have received (or would reasonably be expected to receive)
clinical benefit from treatment with exogenous uridine. It is also to document the continued
clinical benefit of exogenous uridine when patients are switched from oral administration of
uridine to oral administration of uridine triacetate.
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