Tolvaptan for Ascites in Cirrhotic Patients

This study is currently recruiting participants.
Verified February 2014 by University of Florida
Sponsor:
Collaborator:
Otsuka America Pharmaceutical
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01292304
First received: February 7, 2011
Last updated: February 19, 2014
Last verified: February 2014
  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:


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 2014
Estimated Primary Completion Date: August 2014 (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

Contacts
Contact: Giuseppe (Joseph) Morelli, MD 352-273-9500 ext 9467 MORELGJ@MEDICINE.UFL.EDU
Contact: Angela B Martin, RN 352-273-9512 MARTIAB@MEDICINE.UFL.EDU

Locations
United States, Florida
University of Florida Hepatology Recruiting
Gainesville, Florida, United States, 32610-0277
Contact: Giuseppe Morelli, MD    352-273-9500 ext 9467    MORELGJ@MEDICINE.UFL.EDU   
Contact: Angela B Martin, RN    352-273-9512    martiab@medicine.ufl.edu   
Principal Investigator: Giuseppe Morelli, MD         
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: February 19, 2014
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 April 17, 2014