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

Sponsor

Institute of Liver and Biliary Sciences, India (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01384578

Collaborator

(none)

Enrollment

Location

Arms

28.1

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Steatohepatitis	Drug: pentoxiphylline and Vitamin E Drug: Vitamin E	Phase 3

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

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2011

Anticipated Primary Completion Date :

Nov 1, 2013

Anticipated Study Completion Date :

Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pentoxiphylline and Vitamin E	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.
Active Comparator: Vitamin E	Drug: Vitamin E Patients in control group will receive vitamin E 800 IU/day

Arm

Intervention/Treatment

Experimental: pentoxiphylline and Vitamin E

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.

Active Comparator: Vitamin E

Drug: Vitamin E

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

Outcome Measures

Primary Outcome Measures

histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score). [3 Months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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
Impaired renal function
Hypothyroidism