Status:
COMPLETED
Efficacy and Safety of Dapagliflozin in Patients with Non-alcoholic Steatohepatitis
Lead Sponsor:
Cairo University
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Patients with non-alcoholic fatty liver disease (NAFLD) are at increased risk of more aggressive liver disease; non-alcoholic steatohepatitis (NASH) and at a higher risk of death from cirrhosis, hepat...
Eligibility Criteria
Inclusion
- Age range 18-65 years.
- Liver biopsy confirming NASH within 6 months.
- For diabetic patients, the patients should be with stable glycemic control defined as HbA1C \<10%.
Exclusion
- Active viral hepatitis (HBV, HCV).
- Child Pugh B or C cirrhosis.
- Alcohol consumption in the past six months.
- A history of alcoholic liver disease.
- Secondary causes of steatohepatitis.
- Autoimmune hepatitis.
- Celiac disease.
- Hemochromatosis or Wilson's disease.
- Drug induced liver injury (DILI) or patient with history of taking medication(s) that may cause fatty liver (e.g., tamoxifen, valproic acid, amiodarone, methotrexate, steroids, oral contraceptives).
- Obstructive biliary disease.
- Serum alanine aminotransferase (ALT) more than 2.5 folds of UNL.
- History of serious hypersensitivity to dapagliflozin or pioglitazone or any component of the formulation.
- Pregnancy and breastfeeding.
- Renal impairment (eGFR \<45 mL/minute/1.73 m2), end-stage renal disease (ESRD), or patients on dialysis.
- Having any medical condition that would affect metabolism (i.e., known hyperthyroidism or hypothyroidism).
- Hypopituitarism.
- Patients with Type 1 diabetes.
- Starvation.
- Serious medical disease with likely life expectancy less than 5 years.
- Participation in other clinical trial in the 30 days before enrollment.
- Patients who are unwilling or unable to give informed consent.
- Patients on statins.
- Heart failure defined as New York Heart Association (NYHA) class III or IV.
- Recent initiation or change of antidiabetic drugs that influence liver fat including thiazolidinediones, glucagon like peptide 1 receptor agonists or any SGLT2 inhibitor.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05254626
Start Date
August 1 2022
End Date
July 23 2024
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Hepatology and Tropical Medicine Research Institute
Cairo, Cairo Governorate, Egypt