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

Overview

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.

Full Title of Study: “A Randomized Controlled Trial to Study the Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2015

Interventions

  • Drug: S-adenosylmethionine (SAMe)
  • Drug: pentoxiphylline (PTX)

Arms, Groups and Cohorts

  • Experimental: S-adenosylmethionine (SAMe)
  • Active Comparator: pentoxiphylline (PTX)

Clinical Trial Outcome Measures

Primary Measures

  • Biochemical improvement in the form of AST/ALT
    • Time Frame: 1 Years
  • Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter)
    • Time Frame: 1 years

Secondary Measures

  • Metabolic response in form of anthropometry.
    • Time Frame: 1 Years
    • metabolic response in form of anthropometry (BMI, waist circumference).
  • Fasting lipid profiles
    • Time Frame: 1 Years
  • Reduction in uric acid levels
    • Time Frame: 1 Years
  • Reduction in pro- inflammatory cytokines
    • Time Frame: 1 Years
  • Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis.
    • Time Frame: 1 years

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Liver and Biliary Sciences, India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr Devaraja R, MD, Principal Investigator, Institute of Liver and Biliary Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.