Hepatology communications · 2026
Efficacy, safety, and pharmacokinetics of rifaximin in pediatric patients with hepatic encephalopathy in Japan: An open-label study.
СтатьяМногоцентровое исследованиеКлиническое исследование II фазыКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Okajima Hideaki, Tagawa Masashi, Fujisawa Masaki, Ueda Kaoru
Аннотация
BACKGROUND: To evaluate the efficacy, safety, and pharmacokinetics of rifaximin in children with hepatic encephalopathy (HE).
METHODS: We conducted a multicenter, open-label, phase II/III study, comprising a 12-week treatment period, in children aged <18 years with hyperammonemia (≥66 μg/dL) and grade I or II HE or suspected HE, and compared the results with those previously obtained in adults. Patients were treated with 400 mg rifaximin 3 times daily, as for adults. The primary endpoint was the blood ammonia concentration, and other endpoints were changes in mental state and number connection test (NCT)-A and -B results from baseline. The safety endpoints were adverse events and fecal microbial composition. The pharmacokinetics of rifaximin were also assessed.
RESULTS: Of 21 patients (median age 11.0 years old, Q1-Q3 [8.0-14.0]), 18 completed the study, with a median [Q1-Q3] treatment duration of 84.0 [83.0-85.0] days. The most common underlying disease was a congenital portosystemic shunt. Thirteen patients were suspected of having HE, and 8 were diagnosed with coma grade I. The serum ammonia concentration remained lower than that at baseline during treatment with rifaximin, although the difference did not reach statistical significance. There were significant reductions from baseline in the mental state associated with HE and NCT-B results at all time points. No new clinically relevant safety issues or marked changes in the composition of the gut microbiota were identified.
CONCLUSION: This is the first pediatric clinical study to demonstrate the efficacy, safety, and pharmacokinetics of rifaximin in pediatric patients with HE. The efficacy signals were driven primarily by clinical and neurocognitive measures rather than biochemical (ammonia) changes. The safety and pharmacokinetics of rifaximin were similar to those for adult patients.
METHODS: We conducted a multicenter, open-label, phase II/III study, comprising a 12-week treatment period, in children aged <18 years with hyperammonemia (≥66 μg/dL) and grade I or II HE or suspected HE, and compared the results with those previously obtained in adults. Patients were treated with 400 mg rifaximin 3 times daily, as for adults. The primary endpoint was the blood ammonia concentration, and other endpoints were changes in mental state and number connection test (NCT)-A and -B results from baseline. The safety endpoints were adverse events and fecal microbial composition. The pharmacokinetics of rifaximin were also assessed.
RESULTS: Of 21 patients (median age 11.0 years old, Q1-Q3 [8.0-14.0]), 18 completed the study, with a median [Q1-Q3] treatment duration of 84.0 [83.0-85.0] days. The most common underlying disease was a congenital portosystemic shunt. Thirteen patients were suspected of having HE, and 8 were diagnosed with coma grade I. The serum ammonia concentration remained lower than that at baseline during treatment with rifaximin, although the difference did not reach statistical significance. There were significant reductions from baseline in the mental state associated with HE and NCT-B results at all time points. No new clinically relevant safety issues or marked changes in the composition of the gut microbiota were identified.
CONCLUSION: This is the first pediatric clinical study to demonstrate the efficacy, safety, and pharmacokinetics of rifaximin in pediatric patients with HE. The efficacy signals were driven primarily by clinical and neurocognitive measures rather than biochemical (ammonia) changes. The safety and pharmacokinetics of rifaximin were similar to those for adult patients.