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Completed

NCT Number: NCT01292304

Tolvaptan for Ascites in Cirrhotic Patients

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.

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Key information

Conditions

Ascites Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida Hepatology

Gainesville, Florida, 32610-0277, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Tolvaptan

Drug

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

Other names: (SAMSCA)

Primary outcomes

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

    Time frame: Week 12

    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

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

    Time frame: 12 weeks of study drug

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

Secondary outcomes

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

    Time frame: 12 weeks

    Number of patients with reduction of ascites is defined as reduction of weight by at least 2 kg during study drug dosing

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

    Time frame: 12 weeks

    Number of Patients with new episodes of hyponatremia (abnormally low levels of sodium) defined as sodium >130 mmol/L and <135 mmol/L

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

    Time frame: 12 weeks of study drug

    This outcome will describe the average time from baseline for subjects to require a therapeutic paracentesis to remove ascites fluid.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Otsuka America Pharmaceutical

Registry information

Official study title

Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 9, 2011
Registry last updated
Jul 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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