Status:
COMPLETED
Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis
Lead Sponsor:
Al-Azhar University
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
Detailed Description
Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress t...
Eligibility Criteria
Inclusion
- Aged between 18- 60 years old.
- Both sexes
- Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
- clinical examination (obese, high body mass index).
- radiological criteria of fatty liver (abdominal ultrasonography).
- laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
- The ability to give informed consent
- Appropriate exclusion of other liver diseases
Exclusion
- 1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.
- 2\. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.
- 3\. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.
- 4\. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05284448
Start Date
February 1 2022
End Date
October 1 2022
Last Update
June 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.
Cairo, Egypt