TRIAL OF OPC-41061 FOR TREATMENT OF HYPONATREMIA SECONDARY TO LIVER DISORDER

这是一项非肽类血管加压素（V2）受体拮抗剂OPC-41061治疗继发于肝病的低钠血症的多中心、随机、双盲、安慰剂对照、剂量范围探索研究。目标患者入组是在5个月内入组5例患者。本研究将分两个阶段进行，第三个阶段可选：（1）住院6天阶段，用于评估基线特征和开始治疗，（2）门诊阶段，至少进行6次门诊评价（预计6次，如果发生并发症，可能需要额外访视），（3）可选的24小时住院评价，用于进一步的药代动力学研究。GCRC将在评价的所有阶段使用。

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study of a non-peptide vasopressin (V2) receptor antagonist, OPC-41061, for the treatment of hyponatremia secondary to liver disease. The goal patient enrollment is five patients over a five-month period. The study will be conducted in two phases with an optional third phase: (1) inpatient six-day phase for assessment of baseline characteristics and initiation of therapy, (2)outpatient phase with at least six outpatient evaluations (six anticipated, additional visits may be necessary in the event of a complication), (3) optional 24-hour inpatient evaluation for further pharmacokinetic studies. The GCRC will be used during all phases of evaluation.