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

Phase 2

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: Hepar-P; Drug: Placebo for Hepar-P

• Registration Number: NCT01680003
• Lead Sponsor: Nova Laboratories Sdn Bhd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-12
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hepar-P	Hepar-P	Hepar-P: Two capsules (250mg x 2), three times daily, orally
Placebo for Hepar-P	Placebo for Hepar-P	Placebo: Two capsules, three times daily, orally

Primary Outcome Measures

Name	Time	Method
Improvement in serum aspartate aminotransferase and alanine aminotransferase levels	48 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Tengku Ampuan Afzan Hospital; 🇲🇾 Kuantan, Pahang, Malaysia

Kuala Lumpur Hospital; 🇲🇾 Wilayah Persekutuan, Kuala Lumpur, Malaysia

Queen Elizaberth Hospital; 🇲🇾 Kota Kinabalu, Sabah, Malaysia

Ampang Hospital; 🇲🇾 Selangor, Malaysia

Sultamah Bahiyah Hospital; 🇲🇾 Alor Setar, Kedah, Malaysia