Dapagliflozin in the treatment of decompensated liver cirrhosis: phase IIb randomised, controlled clinical trial

Phase 1

• Conditions: Decompensated liver cirrhosis; MedDRA version: 20.0Level: LLTClassification code: 10009214Term: Cirrhosis of liver without mention of alcohol Class: 10019805; MedDRA version: 20.0Level: LLTClassification code: 10009211Term: Cirrhosis liver Class: 10019805; MedDRA version: 21.1Level: LLTClassification code: 10001618Term: Alcoholic cirrhosis of liver Class: 10019805; MedDRA version: 20.0Level: LLTClassification code: 10009213Term: Cirrhosis of liver Class: 10019805; MedDRA version: 20.0Level: LLTClassification code: 10024667Term: Liver cirrhosis Class: 10019805; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2024-511964-95-00
• Lead Sponsor: Azienda Ospedale-Universita Padova

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-13
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Age between 18 and 85 years, Diagnosis of liver cirrhosis, documented on the basis of histological examination and/or clinical and/or instrumental examinations (ultrasonography, CT scan or liver elastography > 15 kPa), Liver cirrhosis decompensation (overt hepatic encephalopathy, clinically significant ascites, hemorrhage from esophageal varices) developed within the past 12 months

Exclusion Criteria

Established hypersensitivity to Dapaglifozin, Patient who is a carrier of TIPS, Active therapy for HCV eradication with Direct Antiviral Agents or terminated < 6 months before, Therapy for HBV suppression with nucleoside/nucleotide analogs started < 6 months before, Active alcohol consumption greater than 21 weekly alcohol units, Presence of at least one episode of acute kidney injury (AKI) in the 4 weeks prior to enrollment, Presence of two or more episodes of urinary tract infection in the 12 months prior to enrollment, Presence of >2 episodes of overt hepatic encephalopathy in the 12 months prior to enrollment, Body mass index (BMI) < 20 kg/m^2, History of prior solid organ transplantation, Inclusion in other clinical trials in the month prior to study initiation, Ongoing therapy with SGLT2 inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin, Ertugliflozin etc), Presence of mental incapacity, complete language barrier, poor social support, or other reasons that, in the opinion of the investigator, may preclude the proper conduct of the study, Refusal or inability to sign informed consent and absence of a legal guardian capable of signing consent., Pregnancy or breastfeeding (in the case of women of childbearing age, they will be asked to maintain effective contraception or, alternatively, abstention from sexual intercourse during the observation period), Hepatocarcinoma outside the Milan criteria (a single nodule<5 cm or multiple nodules [maximum 3], the largest of which =3 cm), Active extrahepatic malignancy, Chronic kidney disease with estimated VFG < 30 ml/min/1.73m2, Other known extrahepatic diseases of severe grade (e.g., heart failure NYHA class = 3; COPD GOLD class = 3; psychiatric disorders);, Diagnosis oftype 1 Diabetes Mellitus and/or previous history of diabetic ketoacidosis, Ascites refractory to diuretic therapy according to International Club of Ascites criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified