Tolvaptan for Ascites in Cirrhotic Patients

Status Completed

Clinical Trial Summary

Open Label Study evaluating the safety and efficacy of tolvaptan in the treatment of ascites in liver cirrhosis. Tolvaptan will be administered in combination with current ascites management.

Clinical Trial Description

This is an open label, 12 week dose escalating pilot study of tolvaptan (initiating at 15 mg a day and increasing to 30 mg a day as tolerated in addition to standard ascites treatment) of 10 cirrhotic subjects meeting all inclusion/exclusion criteria. Subjects are monitored for changes in frequency of paracentesis, quantity of ascites removed, and body weight. Additionally, subjects laboratory values were checked frequently during the first days of dosing to ensure tolerability and slow correction/increase in serum sodium. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01292304
Study type	Interventional
Source	University of Florida
Contact
Status	Completed
Phase	Phase 4
Start date	March 2012
Completion date	January 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01884415` - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis	Phase 3
Recruiting	`NCT05014594` - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT	Phase 2
Not yet recruiting	`NCT03631147` - The Effect of Rifaximin on Portal Vein Thrombosis	N/A
Completed	`NCT04939350` - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed	`NCT02528760` - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis	N/A
Recruiting	`NCT05484206` - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434	Phase 1
Not yet recruiting	`NCT05538546` - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting	`NCT04053231` - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting	`NCT02983968` - Use of the French Healthcare Insurance Database
Completed	`NCT02705534` - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1	Phase 3
Completed	`NCT02596880` - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics	Phase 3
Completed	`NCT02247414` - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection	Phase 4
Completed	`NCT02016196` - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS	Phase 3
Withdrawn	`NCT01956864` - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer	Phase 1
Completed	`NCT02113631` - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir	N/A
Completed	`NCT01362855` - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed	`NCT01447537` - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis	N/A
Active, not recruiting	`NCT01205074` - ¹³C-Methacetin Breath Test (MBT) Methodology Study	Phase 2/Phase 3
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT01231828` - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.	N/A