"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"

NCT07684326 | Recruiting Phase 2 DMC

• 1 other identifier: F PH-BSU-HREC-0001625
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ascites Hepatic

Outcome Measures

Primary Outcomes (1)

• Number of times patient need Paracentesis to control Ascites

  Decrease need for large volume paracentesis in the intervention group than in the control group which indicate better control of Ascites within 3 months from the start of intervention.

  3 months

Secondary Outcomes (1)

• incidence of Cirrhosis sequelae

  3 months

Other Outcomes (1)

• quality of life using SF-36 questionnaire

  3 months

Study Arms (2)

Group A

NO INTERVENTION

Patients will receive standard of care (SoC) regimen only. The SoC included dietary sodium restriction, treatment with diuretics \[combination of a loop diuretic (furosemide 40-160 mg/day or torsemide 5-20 mg/day) and a distal-acting diuretic (spironolactone 50-400 mg/day)\] and large volume paracentesis as needed.

Group B

EXPERIMENTAL

Patients will receive dapagliflozin in addition to standard of care regimen. Based on the pharmacokinetic data of dapagliflozin; Patient with Child Pugh score A and B will receive 10mg/day and patients with Child Pugh score C will receive 5 mg/day.

Drug: Dapagliflozin

Interventions

Dapagliflozin DRUG

Dapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Child Pugh score ≥ 12 or MELD score \> 25.
• Previous history of hypoglycemia or has a previous history of DKA.
• Blood pressure less than 90/60 or need dose of midodrine \>15 mg/day.
• 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.
• Pregnant or lactating female patients.
• Hypersensitivity to dapagliflozin.
• eGFR \< 30 ml/min/1.73 m2
• Had hepatocellular carcinoma or any malignancy.
• Serum sodium level \< 125 mg/dl.
• Portal vein thrombosis.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Haram Hospital

Giza, 12556, Egypt

RECRUITING

MeSH Terms

Interventions

dapagliflozin

Central Study Contacts

Raghda Roshdy

CONTACT

+0282-2162135; Raghda.hussien@pharm.bsu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer in clinical pharmacy

Model Details: An open label prospective parallel two group randomized controlled superiority trials.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Locations

EG (1)