- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07684326
"Exploring the Potential Benefits of Using Dapagliflozin in Cirrhotic Chronic Liver Disease Patients- A Randomized Controlled Trial"
29. juni 2026 opdateret af: Asia Said Toukhy, Beni-Suef University
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
52
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Raghda Roshdy
- Telefonnummer: +0282-2162135
- E-mail: Raghda.hussien@pharm.bsu.edu.eg
Studiesteder
-
-
-
Giza, Egypten, 12556
- Rekruttering
- Haram Hospital
-
Kontakt:
- asia said
- E-mail: asia_said@yahoo.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Group A
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.
|
|
|
Eksperimentel: Group B
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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of times patient need Paracentesis to control Ascites
Tidsramme: 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.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
incidence of Cirrhosis sequelae
Tidsramme: 3 months
|
• Reduced incidence of Cirrhosis sequelae (hepatic encephalopathy, hepatorenal syndrome, spontaneous bacterial peritonitis, variceal bleeding) in the intervention group as compared to control group.
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3 months
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
quality of life using SF-36 questionnaire
Tidsramme: 3 months
|
• Improvement of patient quality of life in the intervention group as compared to control group.
|
3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2026
Primær færdiggørelse (Anslået)
1. juli 2027
Studieafslutning (Anslået)
1. september 2027
Datoer for studieregistrering
Først indsendt
29. juni 2026
Først indsendt, der opfyldte QC-kriterier
29. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- F PH-BSU-HREC-0001625
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