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

This study is currently recruiting participants.
Verified April 2013 by Nova Laboratories Sdn Bhd
Sponsor:
Information provided by (Responsible Party):
Nova Laboratories Sdn Bhd
ClinicalTrials.gov Identifier:
NCT01680003
First received: September 3, 2012
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Non-alcoholic Fatty Liver Disease
Drug: Hepar-P
Drug: Placebo for Hepar-P
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Nova Laboratories Sdn Bhd:

Primary Outcome Measures:
  • Improvement in serum aspartate aminotransferase and alanine aminotransferase levels [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse events reporting, physical examinations and laboratory tests [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: September 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680003

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

No publications provided

Responsible Party: Nova Laboratories Sdn Bhd
ClinicalTrials.gov Identifier: NCT01680003     History of Changes
Other Study ID Numbers: CT11-03
Study First Received: September 3, 2012
Last Updated: April 10, 2013
Health Authority: Malaysia: Ministry of Health

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 22, 2014