Overview

Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
Summary
The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Al-Azhar University
Treatments:
Pentoxifylline
Criteria
Inclusion Criteria:

1. Aged between 18- 60 years old.

2. Both sexes

3. 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).

4. The ability to give informed consent

5. 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.

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