Ascites HepaticPhase 2/3NCT07684326
"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
A Phase 2/3 study testing Dapagliflozin in people with Ascites Hepatic, run by Beni-Suef University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites Hepatic
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2026to Sep 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- eGFR < 30 ml/min/1.73 m2
- Had hepatocellular carcinoma or any malignancy.
- Serum sodium level < 125 mg/dl.
- Portal vein thrombosis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Haram Hospital
Giza, 12556
asia said, asia_said@yahoo.com
About this study
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.
Read the detailed description
Patients diagnosed with cirrhosis and any degree of ascites that led to previous or recent hospital admission and met the inclusion criteria will be randomized into two patient groups. The first patients' group, Group A, 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 LVP as needed. The second patients' group, group B, 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. Patients will be counseled to stay adequately hydrated and avoid alcohol intake at baseline and at every follow-up visit. Adherence, body weight, symptoms of urinary tract infection, and Sodium level will be measured after 1 and 2 weeks from the start of the therapy then at the end of the follow-up period. At the start of participation and at the end of follow up period, a quality of life will be assessed using quality of life questionnaire for chronic liver disease patients. The patient will be interviewed by the principal investigator to fill the questionnaire to ensure understanding of each question.
- Conditions
- Ascites Hepatic
- Being tested
- Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
incidence of Cirrhosis sequelae
- Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascites HepaticStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An open label prospective parallel two group randomized controlled superiority trials.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asia Said Toukhy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684326
- Sponsor's protocol ID
- F PH-BSU-HREC-0001625
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07684326
- Acronym / sponsor ID
- F PH-BSU-HREC-0001625
- Conditions
- Ascites Hepatic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients diagnosed with cirrhosis and any degree of ascites that led to previous or recent hospital admission and met the inclusion criteria will be randomized into two patient groups. The first patients' group, Group A, 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 LVP as needed. The second patients' group, group B, 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. Patients will be counseled to stay adequately hydrated and avoid alcohol intake at baseline and at every follow-up visit. Adherence, body weight, symptoms of urinary tract infection, and Sodium level will be measured after 1 and 2 weeks from the start of the therapy then at the end of the follow-up period. At the start of participation and at the end of follow up period, a quality of life will be assessed using quality of life questionnaire for chronic liver disease patients. The patient will be interviewed by the principal investigator to fill the questionnaire to ensure understanding of each question.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open label prospective parallel two group randomized controlled superiority trials.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: DapagliflozinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinDapagliflozin is sodium glucose cotransporter type 2 inhibitors (SGLT-2i) primary an antidiabetic drug but now used in chronic heart failure and chronic kidney disease. | Drug | Group B |
Primary outcome
Number of times patient need Paracentesis to control Ascites
Time frame: 3 months
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.
1 secondary outcome
incidence of Cirrhosis sequelae
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin in people with Ascites Hepatic, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raghda Roshdy (+0282-2162135, Raghda.hussien@pharm.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of times patient need Paracentesis to control Ascites (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.