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

Non-alcoholic Fatty Liver Disease Clinical Trial

— Hepar-P  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01680003
• Other study ID #: CT11-03
• Status: Recruiting
• Phase: Phase 2
• First received: September 3, 2012
• Last updated: April 10, 2013
• Start date: September 2012
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Nova Laboratories Sdn Bhd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Hepar-P

• Placebo for Hepar-P

Locations

Country	Name	City	State
Malaysia	Sultamah Bahiyah Hospital	Alor Setar	Kedah
Malaysia	Queen Elizaberth Hospital	Kota Kinabalu	Sabah
Malaysia	Tengku Ampuan Afzan Hospital	Kuantan	Pahang
Malaysia	Ampang Hospital	Selangor
Malaysia	Kuala Lumpur Hospital	Wilayah Persekutuan	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Nova Laboratories Sdn Bhd

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events reporting, physical examinations and laboratory tests		48 weeks	Yes
Primary	Improvement in serum aspartate aminotransferase and alanine aminotransferase levels		48 weeks	No
Secondary	Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score		48 weeks	No