Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Phase 3

Completed

• Conditions: NAFLD
• Interventions: Drug: Lubiprostone 24Mcg Oral twice daily

• Registration Number: NCT05768334
• Lead Sponsor: Helwan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen &Hepatitis C virus Antibody).

4. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4<14.6KPa). 7. Hepatic steatosis > 5% with MRI-PDFF.

Exclusion Criteria

• 1. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease).

  2. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993).

  3. Child-Pugh score > 7. 4. Cirrhotic patients diagnosed by fibroScan (F4>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003).

  4. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lubiprostone	Lubiprostone 24Mcg Oral twice daily	50 patients
Control arm	Lubiprostone 24Mcg Oral twice daily	50 patients

Primary Outcome Measures

Name	Time	Method
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).	48 weeks	change in fat quantification

Secondary Outcome Measures

Name	Time	Method
FibroScan with CAP (Controlled Attenuation Parameter)	48 weeks	change in fat quantification

Trial Locations

Locations (1)

National Hepatology and Tropical Medicine Research Institute; 🇪🇬 Cairo, Egypt