Study on Dapagliflozin for Patients with Decompensated Liver Cirrhosis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dapagliflozin in patients with a condition known as decompensated liver cirrhosis. Liver cirrhosis is a disease where the liver becomes severely scarred, and when it is decompensated, it means the liver is no longer able to function properly, leading to serious health issues. The purpose of this study is to evaluate the safety of using dapagliflozin compared to standard medical treatments for this condition.

Participants in the study will be randomly assigned to receive either dapagliflozin or a standard treatment, which may include a placebo. The study will monitor the participants over a period of several months to observe any side effects and to assess the overall health outcomes. The study will also track the occurrence of specific complications related to liver cirrhosis, such as bleeding from veins in the esophagus, confusion due to liver failure (known as hepatic encephalopathy), and fluid buildup in the abdomen (ascites).

Throughout the study, various health markers will be measured to understand the impact of dapagliflozin on liver function and overall health. These include changes in scores that assess liver disease severity, quality of life, and other health indicators. The study aims to provide valuable information on whether dapagliflozin can be a safe and effective treatment option for people with decompensated liver cirrhosis.

1 Joining the study

Upon joining the study, eligibility is confirmed based on age (18 to 85 years) and a diagnosis of liver cirrhosis. This diagnosis must be documented through medical examinations such as histological examination, ultrasonography, CT scan, or liver elastography.

The liver cirrhosis must have shown signs of decompensation, such as hepatic encephalopathy, significant ascites, or bleeding from esophageal varices, within the past 12 months.

2 Medication administration

The medication used in the study is Forxiga (dapagliflozin) 10 mg film-coated tablets.

The tablets are taken orally. The frequency and duration of administration are determined by the study protocol.

3 Monitoring and assessments

The primary focus is on evaluating the safety of dapagliflozin compared to standard medical therapy.

Monitoring includes tracking the incidence of adverse events and serious adverse events.

Secondary assessments involve checking for further liver decompensation, such as variceal bleeding, hepatic encephalopathy, new or recurrent ascites, hepatorenal syndrome, and spontaneous bacterial peritonitis.

Additional evaluations include changes in various health scores and biomarkers at specified intervals: day 28, 56, 84, 112, 140, and 168, with a margin of ±7 days.

4 Completion of the study

The study is expected to conclude by May 30, 2026.

Final assessments will be conducted to evaluate the overall outcomes and any changes in health status from the beginning of the study.

Who Can Join the Study?

Must be between 18 and 85 years old.
Must have a diagnosis of liver cirrhosis, which is a condition where the liver is scarred and doesn’t work properly. This diagnosis should be confirmed by a tissue test (histological examination) or other tests like an ultrasound, CT scan, or a special liver stiffness test called liver elastography showing a result greater than 15 kPa.
Must have experienced liver cirrhosis decompensation in the last 12 months. This means having serious symptoms like overt hepatic encephalopathy (confusion or altered mental state due to liver issues), clinically significant ascites (a large amount of fluid in the belly), or bleeding from esophageal varices (swollen veins in the food pipe).

Who Cannot Join the Study?

Patients with decompensated liver cirrhosis cannot participate. This means the liver is severely damaged and not working properly.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Azienda Ospedaliera di Padova	Padua	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Ackzhzp Ukskd Sghoqtkzg Ldncrc Di Bngfzvv	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.06.2024

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication that helps to lower blood sugar levels in people with type 2 diabetes. In this trial, it is being studied to see if it is safe for patients with decompensated liver cirrhosis, a condition where the liver is severely damaged and cannot function properly. The researchers want to find out if this medication can be used safely in these patients compared to the usual treatments they receive.

Decompensated Liver Cirrhosis – This condition occurs when the liver is severely damaged and can no longer perform its essential functions effectively. It is characterized by the development of complications such as jaundice, ascites (fluid accumulation in the abdomen), and hepatic encephalopathy (confusion due to liver dysfunction). As the disease progresses, patients may experience variceal bleeding, which is bleeding from enlarged veins in the esophagus or stomach. Hepatorenal syndrome, a type of kidney failure, can also occur as a complication. Spontaneous bacterial peritonitis, an infection of the fluid in the abdomen, is another possible complication. The progression of decompensated liver cirrhosis often involves worsening liver function and increased risk of further complications.

Trial ID:

2024-511964-95-00

Protocol code:

SWEET LIVER

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dapagliflozin for Patients with Decompensated Liver Cirrhosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?