A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled Trial to Determine the Efficacy and Safety of HEPAR-P Capsule for the Treatment of Non-alcoholic Fatty Liver Disease (NAFLD)

Nova Laboratories Sdn Bhd5 sites in 1 country50 target enrollmentSeptember 2012

ConditionsNon-alcoholic Fatty Liver Disease

InterventionsHepar-P Placebo for Hepar-P

DrugsHepar-P Placebo for Hepar-P

Overview

Phase: Phase 2
Intervention: Hepar-P
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: Nova Laboratories Sdn Bhd
Enrollment: 50
Locations: 5
Primary Endpoint: Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 2012

End Date

December 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nova Laboratories Sdn Bhd

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Hepar-P

Hepar-P: Two capsules (250mg x 2), three times daily, orally

Intervention: Hepar-P

Placebo for Hepar-P

Placebo: Two capsules, three times daily, orally

Intervention: Placebo for Hepar-P

Outcomes

Primary Outcomes

Improvement in serum aspartate aminotransferase and alanine aminotransferase levels

Time Frame: 48 weeks

Secondary Outcomes

Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score(48 weeks)