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

Institute of Liver and Biliary Sciences, India

Status and phase: Withdrawn; Phase 3

Conditions: Non Alcoholic Steatohepatitis

Treatments: Drug: pentoxiphylline and Vitamin E; Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT01384578

ILBS-NASH-02

Details and patient eligibility

About

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.

Full description

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups

pentoxiphylline and Vitamin E

Experimental group

Treatment:

Drug: pentoxiphylline and Vitamin E

Vitamin E

Active Comparator group

Treatment:

Drug: Vitamin E