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Empagliflozin in Diuretic Refractory Ascites

NCT05013502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-08-02

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Empagliflozin 10 MG

empagliflozin 10mg PO once daily

Sponsors & Collaborators

Principal Investigators

  • Aparna Goel, MD · Clinical Assistant Professor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2023-05-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05013502 on ClinicalTrials.gov