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About
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy. Based on the change in body weight, on Day 7 it will be decided whether to continue administration at the same dose or to increase the dose, and then OPC-41061 will be orally administered for an additional 7 days at either 7.5 mg/day or, if diuretic effect for the initial 7-day administration is insufficient, at an increased dose of 15 mg/day. Plasma drug level, efficacy, and safety of OPC-41061 by 14-day repeated administration will be investigated.
Enrollment
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Inclusion criteria
Patients judged as having cirrhosis* based on previous imaging diagnosis
Patients with ascites in whom the dose of existing diuretics cannot be increased due to risk of adverse drug reactions such as electrolyte abnormalities, or in whom sufficient therapeutic effect cannot be obtained with existing diuretics
Patients who have been receiving oral combination therapy with a loop diuretic and an anti-aldosterone agent from at least 7 days prior to receipt of informed consent, with a dose combination of either loop diuretic equivalent to furosemide 40 mg/day or higher plus spironolactone 25 mg/day or higher, or loop diuretic equivalent to furosemide 20 mg/day or higher plus spironolactone 50 mg/day or higher
Patients who are hospitalized or who can be hospitalized for the trial
Patients capable of giving informed consent
Patients who, together with their partner, agree to use an appropriate method of contraception until 4 weeks after the final trial drug administration
Exclusion criteria
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51 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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