Pentoxiphylline and Vitamin E Versus Vitamin E in Patient... | NCT01384578

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

NCT01384578

Sponsor

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Last Update Posted

Oct 12, 2015Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Non Alcoholic Steatohepatitis

Interventions

pentoxiphylline and Vitamin E
Vitamin E

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funds

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Jun 28, 2011

First Submission Date that Met QC Criteria

Jun 28, 2011

First Posted Date

Jun 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2015

Last Update Posted Date

Oct 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
pentoxiphylline and Vitamin E	Experimental		Drug: pentoxiphylline and Vitamin E
Vitamin E	Active Comparator		Drug: Vitamin E

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pentoxiphylline and Vitamin E	Drug	Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.	pentoxiphylline and Vitamin E

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis (NAS score).		3 Months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shiv Kumar Sarin, MD,DM	Institute of Liver & Biliary Sciences (ILBS)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of liver and Biliary Sciences		New Delhi	National Capital Territory of Delhi	110070	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33772456	Derived	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.

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D001578	Benzopyrans
D011714	Pyrans
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds