3 results
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
(1) To generate new clinical efficacy and safety data to support the registration of Insuman Implantable 400 IU/ml,(2) To ensure the continuation of the treatment of the patients already implanted and avoid pump explantation, up to the approval of…
To assess the bile acid composition of cystic bile and serum pharmacokinetics after a 3-week treatment with UDCA and to correlate pharmacokinetic parameter sof UDCA in bile and serum during steady state.To compare the composition of bile acids and…