NCT05768334CompletedPhase 3
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Helwan University
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
Study Overview
Brief Summary
Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD).
This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI).
Study design: Randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 18-65 years.
- •Cases with NAFLD suspected by abdominal ultrasound or CT.
- •Negative viral hepatitis markers (Hepatitis B surface Antigen &Hepatitis C virus Antibody).
- •Negative autoantibodies (Antinuclear Antibody).
- •Non-cirrhotic patients as diagnosed by fibroScan (F4<14.6KPa).
- •Hepatic steatosis > 5% with MRI-PDFF.
Exclusion Criteria
- •History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).
- •Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).
- •Child-Pugh score >
- •Cirrhotic patients diagnosed by fibroScan (F4>14.6KPa)
- •Calculated Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m
- •Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).
- •Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.
Arms & Interventions
lubiprostone
Active Comparator
50 patients
Intervention: Lubiprostone 24Mcg Oral twice daily (Drug)
Control arm
Placebo Comparator
50 patients
Intervention: Lubiprostone 24Mcg Oral twice daily (Drug)
Outcomes
Primary Outcomes
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
Time Frame: 48 weeks
change in fat quantification
Secondary Outcomes
- FibroScan with CAP (Controlled Attenuation Parameter)(48 weeks)
Investigators
Mohamed El Kassas
Professor and chief of Endemic Medicine Department
Helwan University
Study Sites (1)
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