A 8weeks, double blind, randomized comparative clinical trial comparing the efficacy and safety between udb and ddb for chonic hepatitis: Phase III study

Background/Aims : UDB is a new product of DDB(biphenyl dimethyl dicarboxylate) and UDCA(ursodesoxycholic acid) combination, each of which has been used for managing chronic liver disease. We conducted a phase III randomized clinical trial to compare the efficacy and safety of UDB versus DDB in Korean with chronic liver disease. Methods : 122 voluntary patients with chronic hepatitis who showed increased level of serum alanine aminotransferase(ALT) were randomly allocated to two groups. For 8 weeks, UDB were administered to 61 patients and DDB to 61 patients. To evaluate the efficacy and safety of UDB, we primarily evaluated the degree of decrement of serum ALT level between two groups. Secondarily the proportions of patients who showed normal of ALT at 4th week, 8th week and 10th week in each group were also evaluated. We also examined the effect of underlying etiologies of chronic hepatitis on the results. Adverse effects were monitered during the 8-week treatment and 2-week follow up period. Results : The serum level of ALT of UDB group was lower than that of DDB group at the end of 8-week administration(24. 5±18.5 IU/L vs. 32.3±22.2 IU/L, p=0.038). The proportions of patients who showed normal ALT level in UDB and DDB group were 86.9% and 73.8% at 4th week(p=0.068), 78.7% and 72.7% at 8th week(p=0.077) and 18.0% and 16.4% at 10th week(p=0.638). The viral etiologic factors had no influence on the results. There were no significant adverse effects or toxicities during treatment and follow-up period. Conclusions : UDB is safe and more effective than DDB in the treatment of chronic hepatitis.