Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

Institute of Liver and Biliary Sciences, India

Overview

120 patients of biopsy proven NASH will be randomized into two groups. Cases group will receive combination of pentoxiphylline and Vitamin E, and control group will receive only Vitamin E.

The investigators plan to randomise 120 patients of biopsy proven NASH into cases and control groups. Baseline investigations: Clinical characteristics * Age * Gender * Anthropometry (BMI, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference) * Alcohol intake should be nil Laboratory characteristics * Hemogram, INR, KFT * LFT (especially ALT, GGT) , APRI (AST to platelet ratio) * Fasting Lipid Profile * Other possible etiologies of liver disease (viral markers, ferritin, ANA, IgG, ceruloplasmin ) * HOMA-IR (II) * Serum uric acid levels Liver stiffness * Fibroscan * MR elastography Radiological characteristics * USG abdomen Variceal status by UGI endoscopy Alpha fetoprotein Pro- inflammatory markers * TNF-alpha, IL-6, adiponectin, leptin and osteopontin Liver biopsy and NAS score

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Non Alcoholic Steatohepatitis

Interventions

pentoxiphylline and Vitamin EDRUG

Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.

Vitamin EDRUG

Patients in control group will receive vitamin E 800 IU/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 70 years * Persistently abnormal ALT \>1.2 times upper limit of normal * Histological evidence of NASH/cirrhosis on liver biopsy. ( The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in Zone 3 of the hepatic acinus) Exclusion Criteria: * A known case of Type 2 diabetes mellitus on treatment * Alcohol intake of more than 40gm / week * If they had evidence of cirrhosis with significant portal hypertension * Ongoing total parenteral nutrition/ jejunal-ileal bypass * Other known liver disease (Hepatitis A to E, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis) * Medication like estrogens, amiodarone, MTx, tamoxifen, ATT * Pregnancy or lactation * Hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine ) * Recent retinal/cerebral hemorrhage * Acute myocardial infarction or severe cardiac arrhythmias * Impaired renal function * Hypothyroidism

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).

Time frame: 3 Months

Secondary Outcomes

Response in form of anthropometry , HOMA-IR, fasting lipid profiles, biochemical response in form of normalization of ALT and AST levels and reduction in uric

Time frame: 3 Months

Data from ClinicalTrials.gov

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