Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Al-Azhar University

Status and phase

Completed

Phase 3

Conditions

NASH - Nonalcoholic Steatohepatitis

Treatments

Drug: pentoxifylline (Trental SR®)

Study type

Interventional

Funder types

Other

Identifiers

NCT05284448

312

Details and patient eligibility

About

The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.

Full 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 to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality.

Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged between 18- 60 years old.
Both sexes
Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
1. clinical examination (obese, high body mass index).
2. radiological criteria of fatty liver (abdominal ultrasonography).
3. laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
The ability to give informed consent
Appropriate exclusion of other liver diseases

Exclusion criteria

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.

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.
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.
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