Trial of Hepaguard® in Adults With Nonalcoholic Steatohepatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry LY Chan, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01210989
First received: September 28, 2010
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

Nonalcoholic fatty liver disease is one of the most common chronic liver diseases worldwide. Nonalcoholic steatohepatitis (NASH) is the active form of the disease which runs a progressive course and may result in liver cirrhosis and liver cancer. However, there is yet proven treatment for this disorder. In cell line and animal studies, we have shown that Phyllanthus urinaria can ameliorate NASH by reducing oxidative stress and lipid accumulation. Phyllanthus (Hepaguard) has been used widely by patients with chronic liver diseases, but the efficacy in NASH has not been confirmed in humans.

This study is divided into two parts. In part 1, 60 patients with histology-confirmed NASH will be randomized to receive Hepaguard or placebo for 24 weeks to test the efficacy. Endpoints will be assessed at week 24. The aim of part 2 is to test the durability of Hepaguard. Forty patients originally on Hepaguard will be randomized again to continue Hepaguard for another 24 weeks or stop the treatment. The endpoints at week 48 will be further analyzed.


Condition Intervention
Nonalcoholic Fatty Liver Disease
Drug: Phyllanthus urinaria
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized,Placebo-controlled,Double-blind Trial of Phyllanthus Urinaria (Hepaguard®) in Adults With Nonalcoholic Steatohepatitis

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Histologic NAFLD activity score [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ALT normalization [ Time Frame: week 24 & week 48 ] [ Designated as safety issue: No ]
  • Metabolic endpoints [ Time Frame: Weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]
  • Changes in magnetic resonance spectroscopy [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Liver stiffness measurement [ Time Frame: Weeks 24 and 48 ] [ Designated as safety issue: No ]
  • Biomarkers of NASH and liver fibrosis [ Time Frame: Weeks 12, 24, 36 and 48 ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hepaguard Drug: Phyllanthus urinaria
Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance. At week 24, subjects receiving active Hepaguard will be randomized (1:1) to continue Hepaguard for another 24 weeks or stop treatment.
Other Name: Hepaguard®
Placebo Comparator: Placebo Drug: Placebo
Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or above,
  • Histologic NAFLD activity score 3,
  • Written informed consent

Exclusion Criteria:

  • Positive hepatitis B surface antigen, or anti-hepatitis C virus antibody, or histologic features of an alternative liver disease,
  • Alcohol consumption above 30g per week in men or 20g per week in women,
  • Serum alanine aminotransferase above 10 times the upper limit of normal,
  • Liver decompensation,
  • Evidence of hepatocellular carcinoma currently or in the past 5 years,
  • Type 1 diabetes or insulin treatment,
  • Use of investigational drugs in the last 12 weeks,
  • Terminal illness or cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01210989

Locations
China
Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

Publications:
Lutchman G, Modi A, Kleiner DE, Promrat K, Heller T, Ghany M, Borg B, Loomba R, Liang TJ, Premkumar A, Hoofnagle JH. The effects of discontinuing pioglitazone in patients with nonalcoholic steatohepatitis. Hepatology 2007;46:424-9. 12. Balas B, Belfort R, Harrison SA, Darland C, Finch J, Schenker S, Gastaldelli A, Cusi K. Pioglitazone treatment increases whole body fat but not total body water in patients with non-alcoholic steatohepatitis. J Hepatol 2007;47:565-70.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henry LY Chan, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01210989     History of Changes
Other Study ID Numbers: NAFLD- Hepaguard
Study First Received: September 28, 2010
Last Updated: February 20, 2014
Health Authority: Hong Kong: Department of Health

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

ClinicalTrials.gov processed this record on September 16, 2014