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

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Withdrawn
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
pentoxiphylline and Vitamin E
Vitamin E
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institute of liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pentoxiphylline and Vitamin E

Vitamin E

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
June 28, 2011
Last Updated
October 8, 2015
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT01384578
Brief Title
Pentoxiphylline and Vitamin E Versus Vitamin E in Patients With Non- Alcoholic Steatohepatitis
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funds
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pentoxiphylline and Vitamin E
Arm Type
Experimental
Arm Title
Vitamin E
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
pentoxiphylline and Vitamin E
Intervention Description
Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Description
Patients in control group will receive vitamin E 800 IU/day
Primary Outcome Measure Information:
Title
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
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
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv Kumar Sarin, MD,DM
Organizational Affiliation
Institute of Liver & Biliary Sciences (ILBS)
Official's Role
Study Director
Facility Information:
Facility Name
Institute of liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
33772456
Citation
Kedarisetty CK, Bhardwaj A, Kumar G, Rastogi A, Bihari C, Kumar M, Sarin SK. Efficacy of combining pentoxiphylline and vitamin E versus vitamin E alone in non-alcoholic steatohepatitis- A randomized pilot study. Indian J Gastroenterol. 2021 Feb;40(1):41-49. doi: 10.1007/s12664-020-01131-x. Epub 2021 Mar 27.
Results Reference
derived

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

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