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 (Hepar-P)

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)

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

Study Overview

• Status: Unknown
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Drug: Hepar-P; Drug: Placebo for Hepar-P

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Malaysia
  • Selangor, Malaysia, 68000
    • Recruiting
    • Ampang Hospital
    • Contact: Rosaida Mohd Said, Dr; Phone Number: 03-42896155; Email: drrosaida@moh.gov.my
    • Principal Investigator: Rosaida Mohd Said, Dr
  • Kedah
    • Alor Setar, Kedah, Malaysia, 05460
      • Recruiting
      • Sultamah Bahiyah Hospital
      • Contact: Muhammad Radzi Abu Hassan, Dr; Phone Number: +604-7407814; Email: drradzi91@yahoo.co.uk
      • Principal Investigator: Muhammad Radzi Abu Hassan, Dr
  • Kuala Lumpur
    • Wilayah Persekutuan, Kuala Lumpur, Malaysia, 50586
      • Recruiting
      • Kuala Lumpur Hospital
      • Contact: Shashi Kumar Kumar Bhaskaran, Dr; Phone Number: 5691 03-26155555; Email: dr_shashi@hotmail.com
      • Principal Investigator: Shashi Kumar Menon Bhaskaran, Dr
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • Recruiting
      • Tengku Ampuan Afzan Hospital
      • Contact: Tee Hoi Poh, Dr; Phone Number: 09-5133334; Email: hptee@hotmail.com
      • Principal Investigator: Tee Hoi Poh, Dr
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Recruiting
      • Queen Elizaberth Hospital
      • Contact: Jayaram Menon, Dr; Phone Number: 7117 +(6)088-517555; Email: drmjayaram@gmail.com
      • Principal Investigator: Jayaram Menon, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hepar-P; Hepar-P: Two capsules (250mg x 2), three times daily, orally	Drug: Hepar-P
Placebo Comparator: Placebo for Hepar-P; Placebo: Two capsules, three times daily, orally	Drug: Placebo for Hepar-P

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score	48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events reporting, physical examinations and laboratory tests	48 weeks

Collaborators and Investigators

• Sponsor: Nova Laboratories Sdn Bhd
• Investigators: Principal Investigator: Muhammad Radzi Abu Hassan, Dr, Sultanah Bahiyah Hospital, Alor Star; Principal Investigator: Tan Soek Siam, Dr, Selayang Hospital, Selangor; Principal Investigator: Tee Hoi Poh, Dr, Tengku Ampuau Afzan Hospital, Kuantan; Principal Investigator: Rosaida Mohd Said, Dr, Ampang Hospital, Selangor; Principal Investigator: Shashi Kumar Bhaskaran, Dr, Kuala Lumpur Hospital; Principal Investigator: Jayaram Menon, Dr, Queen Elizaberth Hospital, Sabah

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): October 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 6, 2012

Study Record Updates

• Last Update Posted (Estimate): April 12, 2013
• Last Update Submitted That Met QC Criteria: April 10, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CT11-03