"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
Recruiting
Phase 2Phase 3Interventional Study
Ascites Hepatic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Prevention
Participants needed
52 (estimated)
Sponsor
Beni-Suef University · Other
Who this trial is looking for
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This study aims to evaluate beneficial effects of using dapagliflozin in cirrhotic chronic liver disease patients. We hypnotized that the use of dapagliflozin will be associated with fewer need for large volume paracentesis hence better control of ascites, fewer need for ICU admissions, improvement of patient quality of life, better healthcare cost saving and reduced mortality rate.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.
Exclusion Criteria:
1. Child Pugh score ≥ 12…
Inclusion Criteria:
* Adult patients 18 years of age and older with a diagnosis of liver cirrhosis with any degree of ascites that led to previous or recent hospital admission (determined by clinical findings and imaging) will be included in the study.
Exclusion Criteria:
1. Child Pugh score ≥ 12 or MELD score \> 25.
2. Previous history of hypoglycemia or has a previous history of DKA.
3. Blood pressure less than 90/60 or need dose of midodrine \>15 mg/day.
4. Previous history of recurrent urinary tract infections (more than 2 infections in the last 6 months) or anatomic urologic defects that predispose to urinary tract infection.
5. Pregnant or lactating female patients.
6. Hypersensitivity to dapagliflozin.
7. eGFR \< 30 ml/min/1.73 m2
8. Had hepatocellular carcinoma or any malignancy.
9. Serum sodium level \< 125 mg/dl.
10. Portal vein thrombosis.
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