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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01680003
Other study ID # CT11-03
Secondary ID
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


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
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