NASH - Nonalcoholic Steatohepatitis
Conditions
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 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.
Interventions
DRUGpentoxifylline (Trental SR®)
400 mg three times daily
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Clinical trial, parallel, randomized, prospective, controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in liver aminotransferases(ALT and AST) | 6 months compared to the baseline | Difference between last and first measurements |
| NAFLD fibrosis score (NFS) | 6 months compared to the baseline | Change in NAFLD fibrosis score (NFS) (lower score means better outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Aspartate (AST) to Platelet Ratio Index (APRI) score: | 6 months compared to the baseline | Change in (APRI) score (lower score means better outcome). |
| The Fibrosis-4 (FIB-4) values: | 6 months compared to the baseline | Change in (FIB-4) values (lower values means better outcome). |
| Serum Alkaline Phosphatase level (ALP) | 6 months compared to the baseline | Change in ALP serum level as inflammatory markers of NASH |
| Serum Gamma-glutamyl Transferase level (GGT) | 6 months compared to the baseline | Change in GGT serum level as inflammatory markers of NASH |
| Fasting blood glucose level | 6 months compared to the baseline | Change in fasting blood glucose for patients with T2DM |
| Waist circumference | 6 months compared to the baseline | Change in waist circumference |
| Change in anthropometric measures | 6 months compared to the baseline | including BMI etc. |
| Lipid profile | 6 months compared to the baseline | Change in serum lipids |
| Glycated hemoglobin (HbA1C) | 6 months compared to the baseline | Change in HbA1C level for patients with T2DM |
| Serum total and direct bilirubin. | 6 months compared to the baseline | Change in levels of serum total and direct bilirubin. |
| Drugs adverse events | 6 months compared to the baseline | Assessment of safety by reporting any adverse events |
Countries
Egypt
Outcome results
None listed