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

October 8, 2015 updated by: Institute of Liver and Biliary Sciences, India

A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pentoxiphylline and Vitamin E
Drug: pentoxiphylline and Vitamin E
Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.
Active Comparator: Vitamin E
Drug: Vitamin E
Patients in control group will receive vitamin E 800 IU/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Liver and Biliary Sciences, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

June 28, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimate)

June 29, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ILBS-NASH-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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