Phase 4 N=10 Treatment

Tolvaptan for Ascites in Cirrhotic Patients

Ascites · Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT01292304 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Jul 2015

Primary outcome: Primary: Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid) — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tolvaptan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Worsening Ascites (Increase in Number of Paracentesis Procedures to Remove 2 Liters of Ascites Fluid)	—	—
PRIMARY Number of Subjects With Worsening Ascites (Defined as Greater Than 2 kg Weight Gain)	7	—
SECONDARY Number of Patients With Reduction of Ascites (Weight Loss of 2 kg or More)	—	—
SECONDARY Number of Patients With Abnormally Low Levels of Sodium (Sodium Levels Between 130 mmol/L and 135 mmol/L)	1	—
SECONDARY Time From Baseline to Worsening Ascites (Requiring 1 or More Therapeutic Paracentesis to Remove Ascites Fluid)	27	—

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.

Eligibility 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 3 mg/dl
serum sodium < 125 meQ (milliequivalent)/L
serum potassium <3.5 meQ/L

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01292304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.