![]() ![]() ![]() Finally, the proportion of patients who met sBA R was re-evaluated to include the last available sBA assessment for early-exit patients. Using this per-protocol definition, rates of sBA R excluding the contribution of UDCA were also analysed. The PEDFIC 1 per-protocol definition of sBA R was based on average measurements taken at weeks 22 and 24 those not meeting this criteria, including early-exit patients, were considered nonresponders (NRs). The threshold for sBA R was sBAs ≤70 μmol/L or sBAs reduced ≥70% from baseline (BL). Concomitant UDCA was allowed provided the patient’s dose was stable. ![]() Patients eligible for PEDFIC 1 had elevated sBAs at screening. Here, we evaluated the effect of concomitant ursodeoxycholic acid (UDCA) on sBA concentrations in odevixibat-treated patients from PEDFIC 1 (n=42) who met sBA response (R) criteria or not we also assessed whether excluding UDCA concentrations from total sBAs altered the proportion of patients with sBA R. Odevixibat was approved in 2021 in the European Union for treatment of PFIC in patients ≥6 months old. Children with progressive familial intrahepatic cholestasis (PFIC) who received odevixibat in the 24-week PEDFIC 1 study had significant reductions in total serum bile acids (sBAs) vs placebo-treated patients. ![]()
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