Empagliflozin in Diuretic Refractory Ascites

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT05013502
Phase
PHASE1
Status
Completed

Conditions

  • Ascites
  • Ascites Hepatic
  • Cirrhosis
  • Liver Cirrhosis
  • Sodium-Glucose Transporter 2 Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Ascites is the most frequent complication of liver cirrhosis and results in increased morbidity and mortality but current medical management options are limited. Here, the investigators will conduct an interventional single-arm pilot clinical trial toevaluate the feasibility of empagliflozin in managing diuretic-resistant ascites in patients with decompensated cirrhosis. This single site, open label pilot study will enroll participants with decompensated cirrhosis at a single site. Participants will receive empagliflozin 10mg oral tablets once daily for 12 weeks with monitoring for safety and adverse events.

Key Dates

Start date
Nov 15, 2021
Status verified
Jul 2023
Primary completion
May 30, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin 10mg PO daily for 12 weeks
    Single arm trial

Primary Outcome Measure

Participant retention rate as a measure of study feasibility [ Time Frame: Baseline to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Digestive Health ClinicRedwood CityCalifornia94060-

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By research site
Stanford University Digestive Health Clinic· Redwood City, CA

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