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

• Status: Withdrawn
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: alpha-Tocopherol; Pentoxifylline; Tocopherols; Tocotrienols; Vitamin E; Vitamins

Criteria

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