Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 250 mg) |
Drug Class | Antihelmintics |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of fascioliasis in patients 6 years of age and older.
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Summary
- Egaten (triclabendazole) is indicated for the treatment of fascioliasis in patients 6 years of age and older.
- This summary is based on the review of one randomized controlled trial(s). [1]
- The study assessed the effects of triclabendazole on QTc interval prolongation in 45 healthy participants, finding the highest mean placebo-corrected change from baseline in QTcF (ΔΔQTcF) was 9.2 ms at the therapeutic dose and 21.7 ms at the supratherapeutic dose, with an upper limit of the two-sided 90% confidence interval exceeding 10 ms at all time points except predose on day 4 in the therapeutic group.
- No clinically significant effects on heart rate, cardiac conduction, or adverse events were observed, including no deaths, serious adverse events, or treatment-emergent adverse events leading to discontinuation.
- Cardiac Effects: Triclabendazole administration at therapeutic and supratherapeutic doses led to a mean placebo-corrected change in QTcF (ΔΔQTcF) of 9.2 ms and 21.7 ms, respectively, on day 4. The upper limit of the 90% confidence interval exceeded 10 ms at most time points, indicating a potential effect on cardiac repolarization, though no clinically significant effects on heart rate or cardiac conduction were observed.
- Adverse Events: No deaths, serious adverse events, study discontinuations due to treatment-emergent adverse events, or clinically relevant abnormalities in laboratory evaluations and vital signs were reported.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Egaten (triclabendazole) Prescribing Information. | 2022 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Effects of triclabendazole and its metabolite exposure on the heart-rate-corrected QT intervals: a randomized, placebo- and positive-controlled thorough QT study in healthy individuals. | 45Subjects F: 20% M: 80% | 2023 | Clinical and Translational Science |
Sex Distribution:
F:20%
M:80%
45Subjects
Year:
2023
Source:Clinical and Translational Science