NCT03107091

Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites

Safety and Efficacy of Low-dose Terlipressin Delivered by Continuous Intravenous Infusion in Patients With Cirrhosis and Ascites Refractory to, or Intolerant of, Diuretic Therapy, Requiring Large Volume Paracentesis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: BioVie Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cirrhosis
• Ascites Hepatic

Interventions

Type	Name	Description
DRUG	Terlipressin acetate continuous infusion	Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days

Timeline

• Start date: 2017-07-15
• Primary completion: 2019-04-01
• Completion: 2019-04-25
• First posted: 2017-04-11
• Last updated: 2021-07-13
• Results posted: 2021-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study