Tolvaptan for Ascites in Cirrhotic Patients

NCT01292304 | Completed Phase 4 Results

• 1 other identifier: 156-IST-10-06
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ascites; Cirrhosis

Keywords

Cirrhotic; Tolvaptan; v2 receptor antagonist

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)

  Increase in number of therapeutic paracentesis (removal of \> 2 litres of ascites fluid) during 12 weeks of study drug dosing versus 12 weeks before study drug dosing

  Week 12

• Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)

  This outcome will provide the number of subjects with a weight increase of \> 2kg from baseline (worsening ascites)

  12 weeks of study drug

Secondary Outcomes (3)

• Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)

  12 weeks

• Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)

  12 weeks

• Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)

  12 weeks of study drug

Study Arms (1)

Tolvaptan

EXPERIMENTAL

Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability

Drug: Tolvaptan

Interventions

Tolvaptan DRUG

Oral administration once daily Dosage will range from 15 mg to 30 mg

Also known as: (SAMSCA)

Tolvaptan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cirrhosis of liver confirmed by histology and/or combination of ultrasound or endoscopic examination with laboratory evidence
• Clinically evident ascites treated by diet and/or diuretics
• History of 1 or more therapeutic paracentesis in the previous 6 months.

You may not qualify if:

• History of variceal bleeding
• Current or history of Gastrointestinal bleeding within 10 days of screening
• Ascites from another cause other than liver cirrhosis (i.e. cardiac origin, peritoneal infection, or peritoneal carcinoma)
• INR (International normalized ratio) \> 3.0, neutrophils \<1500 cell/μl, platelets \< 40,000/μl
• serum bilirubin \> 3 mg/dl
• serum sodium \< 125 meQ (milliequivalent)/L
• serum potassium \<3.5 meQ/L

Sponsors & Collaborators

• University of Florida: lead
• Otsuka America Pharmaceutical: collaborator

Study Sites (1)

University of Florida Hepatology

Gainesville, Florida, 32610-0277, United States

Location

MeSH Terms

Conditions

Ascites; Fibrosis

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Giuseppe (Joseph) Morelli, MD
• Organization: University of Florida

giuseppe.morelli@medicine.ufl.edu

352-273-9508

Study Officials

• Giuseppe (Joseph) Morelli, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: July 27, 2015
• Results First Posted: July 27, 2015

Record last verified: 2015-06

Locations

US (1)