Trial reportJournal of Korean medical science2026
Standard-Dose Ursodeoxycholic Acid Improves Biochemical Liver Function and Fibrosis in Chronic Liver Disease: Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Trial report in Journal of Korean medical science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06272630 (A Multicenter, Randomized, Placebo Controlled, Double-blinded, Phase 4 Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Multicenter, Randomized, Placebo Controlled, Double-blinded, Phase 4 Study to Evaluate the Efficacy and Safety of DWJ1464 in Patients with Chronic Liver Disease
Who cites it
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Authors and funding
23 authors.
Funding
Abstract
backgroundThis study evaluated the efficacy and safety of standard-dose ursodeoxycholic acid (UDCA; fixed daily dose of 300 mg/day) compared with placebo, in patients with chronic liver disease.
methodsA multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial was conducted in academic hospitals in South Korea. Patients with chronic liver disease and abnormal serum alanine aminotransferase (ALT) levels in at least two consecutive results prior to screening, persisting for at least 6 months, were randomly assigned to receive 100 mg UDCA or placebo three times daily for 8 weeks. The primary endpoint was the mean relative change in ALT levels from baseline. The secondary endpoints included changes in fibrosis and drug-related adverse events.
resultsA total of 262 patients were analyzed (132 in the UDCA group and 130 in the placebo group). By week 8, there was a significantly greater reduction in serum ALT levels from baseline in the UDCA-treated patients than in the placebo group (-14.70 vs. -5.51 U/L;
conclusionIn patients with chronic liver disease, 100 mg UDCA three times daily for 8 weeks improved ALT levels and fibrosis, and had a favorable safety profile.
trial registrationClinicalTrials.gov Identifier: NCT06272630.
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