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Clinical Trial Summary

Low-dose continuous infusion of terlipressin will be administered to six cirrhotic patients with refractory ascites.


Clinical Trial Description

Terlipressin continuous infusion will be adminstered via an ambulatory pump initially for 7 days in a clinical pharmacology unit. Serial blood draws for pharmacokinetic analysis will be performed to determine steady state concentration of both terlipressin and 8-lysine-vasopressin during infusion. After establishing safety and tolerance of infusion for 7 days, patients will be transitioned to an outpatient setting where they will be treated with terlipressin continuous infusion for an additional 21 days, monitored daily by home care nurses. A total of 6 patients will be treated. Monitoring will include successful management of ascites, with reduction in paracentesis procedures and decreased ascites fluid volume, further supported by improvement in renal function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03107091
Study type Interventional
Source BioVie Inc.
Contact
Status Completed
Phase Phase 2
Start date July 15, 2017
Completion date April 25, 2019

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