The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

Steatohepatitis, Nonalcoholic Clinical Trial

Official title:

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080947
• Other study ID #: 002017
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 1, 2019
• Est. completion date: March 15, 2022

Study information

• Verified date: March 2022
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 15, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.

Exclusion Criteria:

• The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis, Nonalcoholic

Intervention

Drug:
• Control group
patients received matching-image placebo once daily at bedtime for 12 weeks.
• Montelukast group
patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibro-scan score	change in liver stiffness measurement (Fibro-scan score)	At baseline and after 12 weeks of intervention
Primary	Liver Panel	Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L	after 12 weeks of intervention
Secondary	HOMA-IR	Homeostatic Model Assessment of Insulin Resistance	after 12 weeks of intervention
Secondary	8-OHdG	Serum level of 8-OHdG	after 12 weeks of intervention
Secondary	TNF-Alpha	Serum level of TNF-Alpha	after 12 weeks of intervention
Secondary	hyaluronic acid	Serum level of hyaluronic acid	after 12 weeks of intervention
Secondary	TGF-ß1	Serum level of TGF-ß1	after 12 weeks of intervention
Secondary	Assessment of drugs tolerability: Side effects	Side effects of montelukast	after 12 weeks of intervention