Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of Non-alcoholic Fatty Liver Disease for a treatment period of 48 weeks

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nova Laboratories Sdn Bhd

Criteria

Inclusion Criteria:

• Male or non-pregnant females age 18 years or older

• Written informed consent obtained from patient or parents/ guardian

• Elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5times the upper limit of the normal range

• Patients with liver biopsy confirmed possible or definite steatohepatitis within the past 12 months prior to enrolment into the trial

• Possible steatohepatitis with activity score ≥3 OR definite steatohepatitis with activity score ≥5

• A score of at least 1 for hepatocellular ballooning

Exclusion Criteria:

• Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test

• Participation in any trial in which the patient received an investigational product within 30 days preceding the screening phase of this study

• Those persons directly involved in the conduct of the study

• Alcohol consumption of more than 20g per day for women or more than 30g per day for men for at least 3 consecutive months during the previous 5 years, as assessed with the use of the Lifetime Drinking History questionnaire and the interview version of the Alcohol Use and Disorders Identification Test (AUDIT)

• History of cirrhosis, hepatitis C or other liver diseases

• History of heart failure (New York Association Class II to IV)

• History of taking medications known to cause steatohepatitis

• Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study