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

This study is currently recruiting participants.
Verified July 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01384578
First received: June 28, 2011
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Non Alcoholic Steatohepatitis
 Drug: pentoxiphylline and Vitamin E
Drug: Vitamin E
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Resource links provided by NLM:

MedlinePlus related topics: Vitamin E
U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score). [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384578

Contacts
Contact: Ankit Bhardwaj +91-9717270640 bhardwaj.ankit3@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Chandan Kumar, MD     011-46300000     <drchandankn@gmail.com>,    
Contact: Ankit Bhardwaj     011-46300000 ext 1032     bhardwaj.ankit3@gmail.com    
Principal Investigator: Chandan Kumar, MD            
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Study Director: Shiv Kumar Sarin, MD,DM Institute of Liver & Biliary Sciences (ILBS)
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01384578     History of Changes
Other Study ID Numbers: ILBS NASH 01
Study First Received: June 28, 2011
Last Updated: July 3, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases
Pentoxifylline
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013