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Tolvaptan for Ascites in Cirrhotic Patients

This study has suspended participant recruitment.
(Recruitment suspended based on recent SAMSCA® label change related to use in patients with underlying liver disease)
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01292304
First received: February 7, 2011
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Ascites
Cirrhosis
 Drug: Tolvaptan
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Center, Open Labeled Pilot Study Evaluating the Safety and Efficacy of Tolvaptan in Patients With Cirrhotic Ascites

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
Drug Information available for: Tolvaptan
U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Number of patients with worsening ascites [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Increase in # of therapeutic paracentesis (removal of > 2 litres of ascites fluid) or weight increase of > 2kg from baseline


Secondary Outcome Measures:
  • Number of patients with reduction of ascites [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Reduction of weight by at least 2 kg or reduction in frequency/amount of paracentesis compared to baseline without any increase in diuretic treatment or therapeutic paracentesis.

  • Number of Patients with Potentially Clinically Significant Abnormal Labs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Number of Patients with Potentially Clinically Significant Abnormal Labs as defined in the protocol


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tolvaptan
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
Oral administration once daily Dosage will range from 15 mg to 30 mg
Other Name: (SAMSCA)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292304

Locations
United States, Florida
University of Florida Hepatology
Gainesville, Florida, United States, 32610-0277
Sponsors and Collaborators
University of Florida
Otsuka America Pharmaceutical
Investigators
Principal Investigator: Giuseppe (Joseph) Morelli, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01292304     History of Changes
Other Study ID Numbers: 156-IST-10-06
Study First Received: February 7, 2011
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Cirrhotic
Tolvaptan
v2 receptor antagonist

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
 Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013