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

Phase 3

Withdrawn

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Drug: pentoxiphylline and Vitamin E; Drug: Vitamin E

• Registration Number: NCT01384578
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-06-28
• Study First Posted: 2011-06-29
• Study Start: 2011-07
• Status Verified: 2012-07
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pentoxiphylline and Vitamin E	pentoxiphylline and Vitamin E	-
Vitamin E	Vitamin E	-

Primary Outcome Measures

Name	Time	Method
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).	3 Months

Secondary Outcome Measures

Name	Time	Method
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	3 Months

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India