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

NCT01384578 | Withdrawn Phase 3

• 1 other identifier: ILBS-NASH-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

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

  3 Months

Secondary Outcomes (1)

• 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

Study Arms (2)

pentoxiphylline and Vitamin E

EXPERIMENTAL

Drug: pentoxiphylline and Vitamin E

Vitamin E

ACTIVE COMPARATOR

Drug: Vitamin E

Interventions

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

Vitamin E DRUG

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

Vitamin E

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 33772456 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shiv Kumar Sarin, MD,DM

  Institute of Liver & Biliary Sciences (ILBS)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2012-07

Locations

IN (1)