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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01384578
Recruitment Status : Withdrawn (Lack of funds)
First Posted : June 29, 2011
Last Update Posted : October 12, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Drug: pentoxiphylline and Vitamin E Drug: Vitamin E Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
Study Start Date : July 2011
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

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

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

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01384578

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Institute of liver and Biliary Sciences
New Delhi, Delhi, India, 110070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
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Study Director: Shiv Kumar Sarin, MD,DM Institute of Liver & Biliary Sciences (ILBS)

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Responsible Party: Institute of Liver and Biliary Sciences, India Identifier: NCT01384578     History of Changes
Other Study ID Numbers: ILBS-NASH-02
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: July 2012

Additional relevant MeSH terms:
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Vitamin E
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Vasodilator Agents
Free Radical Scavengers