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

Non Alcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01384578
• Other study ID #: ILBS-NASH-02
• Status: Withdrawn
• Phase: Phase 3
• First received: June 28, 2011
• Last updated: October 8, 2015
• Start date: July 2011
• Est. completion date: November 2013

Study information

• Verified date: July 2012
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

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.
• Vitamin E
Patients in control group will receive vitamin E 800 IU/day

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).		3 Months	No
Secondary	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		3 Months	No