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

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768334
• Other study ID #: 11-2020
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: December 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Lubiprostone 24Mcg Oral twice daily
The patients will be randomized (closed envelopes) into one of two groups: Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.

Locations

Country	Name	City	State
Egypt	National Hepatology and Tropical Medicine Research Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).	change in fat quantification	48 weeks
Secondary	FibroScan with CAP (Controlled Attenuation Parameter)	change in fat quantification	48 weeks