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

NCT01680003 | Unknown Phase 2

• 1 other identifier: CT11-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in serum aspartate aminotransferase and alanine aminotransferase levels

  48 weeks

Secondary Outcomes (1)

• Histologic findings including degree of steatosis, lobular inflammation, hepatocellular ballooning and fibrosis and overall disease activity score

  48 weeks

Other Outcomes (1)

• Adverse events reporting, physical examinations and laboratory tests

  48 weeks

Study Arms (2)

Hepar-P

EXPERIMENTAL

Hepar-P: Two capsules (250mg x 2), three times daily, orally

Drug: Hepar-P

Placebo for Hepar-P

PLACEBO COMPARATOR

Placebo: Two capsules, three times daily, orally

Drug: Placebo for Hepar-P

Interventions

Hepar-P DRUG

Hepar-P

Placebo for Hepar-P DRUG

Placebo for Hepar-P

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Laboratories Sdn Bhd: lead

Study Sites (5)

Sultamah Bahiyah Hospital

Alor Star, Kedah, 05460, Malaysia

RECRUITING

Kuala Lumpur Hospital

Wilayah Persekutuan, Kuala Lumpur, 50586, Malaysia

RECRUITING

Tengku Ampuan Afzan Hospital

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Queen Elizaberth Hospital

Kota Kinabalu, Sabah, 88586, Malaysia

RECRUITING

Ampang Hospital

Kuala Selangor, Selangor, 68000, Malaysia

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 6, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

MY (5)