Back to resultsEfficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Primary Purpose
NAFLD
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Lubiprostone 24Mcg Oral Cap
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD
Eligibility Criteria
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.
Sites / Locations
- National Hepatology and Tropical Medicine Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
lubiprostone
Control arm
Arm Description
50 patients
50 patients
Outcomes
Primary Outcome Measures
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
change in fat quantification
Secondary Outcome Measures
FibroScan with CAP (Controlled Attenuation Parameter)
change in fat quantification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05768334
Brief Title
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Official Title
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helwan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
lubiprostone
Arm Type
Active Comparator
Arm Description
50 patients
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
50 patients
Intervention Type
Drug
Intervention Name(s)
Lubiprostone 24Mcg Oral Cap
Intervention Description
The patients will be randomized (closed envelopes) into one of two groups:
Fifty patients will receive lubiprostone 24 mcg (microgram) per day.
Fifty patients will receive no medication (control group). All patients will be followed for one year.
Primary Outcome Measure Information:
Title
MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).
Description
change in fat quantification
Time Frame
1 year
Secondary Outcome Measure Information:
Title
FibroScan with CAP (Controlled Attenuation Parameter)
Description
change in fat quantification
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed E El Kassas, MD, PhD
Phone
+201114455552
Email
m_elkassas@hq.helwan.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hala Moustafa
Phone
+201060066770
Email
اhalamostafa27@yahoo.com
Facility Information:
Facility Name
National Hepatology and Tropical Medicine Research Institute
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala Moustafa
Phone
01060066770
Email
halamostafa@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease
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