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The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis

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: NCT02231333
Recruitment Status : Unknown
Verified August 2014 by Institute of Liver and Biliary Sciences, India.
Recruitment status was:  Recruiting
First Posted : September 4, 2014
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. It is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis. NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment available till date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. Role of SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. However the usefulness of SAMe in NAFLD is not known till now. Hence this study has been designed.

Condition or disease Intervention/treatment Phase
Non-alcoholic Steatohepatitis Drug: S-adenosylmethionine (SAMe) Drug: pentoxiphylline (PTX) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Study the Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis.
Study Start Date : June 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: S-adenosylmethionine (SAMe) Drug: S-adenosylmethionine (SAMe)
Active Comparator: pentoxiphylline (PTX) Drug: pentoxiphylline (PTX)

Primary Outcome Measures :
  1. Biochemical improvement in the form of AST/ALT [ Time Frame: 1 Years ]
  2. Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter) [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Metabolic response in form of anthropometry. [ Time Frame: 1 Years ]
    metabolic response in form of anthropometry (BMI, waist circumference).

  2. Fasting lipid profiles [ Time Frame: 1 Years ]
  3. Reduction in uric acid levels [ Time Frame: 1 Years ]
  4. Reduction in pro- inflammatory cytokines [ Time Frame: 1 Years ]
  5. Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis. [ Time Frame: 1 years ]

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 (Non alcoholic Steatohepatitis) on liver biopsy. The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and fibrosis up to stage 3 as per Burnt stating.

Exclusion Criteria:

  • Alcohol intake of more than 40gm / week with features suggestive chronic liver disease .
  • Other known cause of chronic liver disease like Hepatitis B,C, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, PSC (Primary Sclerosis Cholangitis).
  • Patient on Medication like estrogens, amiodarone, MTx, tamoxifen, ATT (Antitubercular Treatment)
  • Pregnancy or lactation
  • Hypersensitivity to methylxanthines (e.g., caffeine, theophylline,)
  • Recent retinal/cerebral hemorrhage
  • Acute myocardial infarction or severe cardiac arrhythmias.
  • Impaired renal function.

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): NCT02231333

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Contact: Dr Devaraja R, MD 011-46300000

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Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr Devraj K, MD    011-46300000   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India Identifier: NCT02231333     History of Changes
Other Study ID Numbers: ILBS-NASH-01
First Posted: September 4, 2014    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: August 2014

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