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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02231333
• Date of registration: 30/08/2014
• Prospective Registration: No
• Primary sponsor: Institute of Liver and Biliary Sciences, India
• Public title: The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis
• Scientific title: A Randomized Controlled Trial to Study the Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis.
• Date of first enrolment: July 1, 2013
• Target sample size: 122
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02231333
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Devaraja R, MD
• Affiliation: Institute of Liver and Biliary Sciences

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non-alcoholic Steatohepatitis

Intervention(s)

Drug: pentoxiphylline (PTX)

Drug: S-adenosylmethionine (SAMe)

Primary Outcome(s)

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 Outcome(s)

Metabolic response in form of anthropometry. [Time Frame: 1 Years]

Fasting lipid profiles [Time Frame: 1 Years]

Reduction in pro- inflammatory cytokines [Time Frame: 1 Years]

Reduction in uric acid levels [Time Frame: 1 Years]

Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis. [Time Frame: 1 years]

Secondary ID(s)

ILBS-NASH-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors