Non-alcoholic Fatty Liver Disease
Conditions
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
Interventions
DRUGHepar-P
DRUGPlacebo for Hepar-P
Sponsors
Nova Laboratories Sdn Bhd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in serum aspartate aminotransferase and alanine aminotransferase levels | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score | 48 weeks |
Other
| Measure | Time frame |
|---|---|
| Adverse events reporting, physical examinations and laboratory tests | 48 weeks |
Countries
Malaysia
Outcome results
None listed