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Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

A Randomized Controlled Project to Study the Efficacy of Combined Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis

NCT01384578•Institute of Liver and Biliary Sciences, India

View on ClinicalTrials.gov

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.

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Key Dates

Start Date

July 1, 2011

Primary Completion Date

November 1, 2013

Completion Date

November 1, 2013

Last Updated

October 12, 2015

Conditions

Non Alcoholic Steatohepatitis

Interventions

pentoxiphylline and Vitamin E

DRUG

Vitamin E

DRUG

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

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Non Alcoholic SteatohepatitisHyperuricemia

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COMPLETEDPHASE2

A Phase 2b Study of Icosabutate in Fatty Liver Disease

NCT04052516

Non Alcoholic Steatohepatitis (NASH)

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TERMINATED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Comparative Study Between Febuxostat Versus Vitamin E in Non-alcoholic Steatohepatitis Patients With Hyperuricemia

A Phase 2b Study of Icosabutate in Fatty Liver Disease

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

Effect of Patient Demographics, Comorbidities, and Medications on Severity of NASH Fibrosis

Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)