Clinical trial NCT01680003: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Nova Laboratories Sdn Bhd
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Improvement in serum aspartate aminotransferase and alanine aminotransferase levels
timeFrame: 48 weeks
Secondary outcomes:
measure: Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score
timeFrame: 48 weeks
Other outcomes:
measure: Adverse events reporting, physical examinations and laboratory tests
timeFrame: 48 weeks
Locations:
city: Alor Setar
country: Malaysia
facility: Sultamah Bahiyah Hospital
state: Kedah
city: Wilayah Persekutuan
country: Malaysia
facility: Kuala Lumpur Hospital
state: Kuala Lumpur
city: Kuantan
country: Malaysia
facility: Tengku Ampuan Afzan Hospital
state: Pahang
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizaberth Hospital
state: Sabah
city: Selangor
country: Malaysia
facility: Ampang Hospital
Study officials:
affiliation: Sultanah Bahiyah Hospital, Alor Star
name: Muhammad Radzi Abu Hassan, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Selayang Hospital, Selangor
name: Tan Soek Siam, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Tengku Ampuau Afzan Hospital, Kuantan
name: Tee Hoi Poh, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ampang Hospital, Selangor
name: Rosaida Mohd Said, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuala Lumpur Hospital
name: Shashi Kumar Bhaskaran, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizaberth Hospital, Sabah
name: Jayaram Menon, Dr
role: PRINCIPAL_INVESTIGATOR
References: