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Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients

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ClinicalTrials.gov Identifier: NCT02491905
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : July 8, 2015
Sponsor:
Information provided by (Responsible Party):
Huons Co., Ltd.

Brief Summary:
This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Drug: HL tablet Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients
Study Start Date : November 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Experimental: low dose HL tablet
HL tablet which contains 66.7mg of active compound by oral administration, twice daily in an hour after meal
Drug: HL tablet
Experimental: high dose HL tablet
HL tablet which contains 200mg of active compound by oral administration, twice daily in an hour after meal
Drug: HL tablet
Placebo Comparator: placebo group
Placebo by oral administration, twice daily in an hour after meal
Drug: Placebo



Primary Outcome Measures :
  1. To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Changes in Alanine Transaminase (ALT) [ Time Frame: 8 and 12 week ]
  2. Changes in Asparate Transaminase (AST) [ Time Frame: 8 and 12 week ]
  3. Changes in cholesterol [ Time Frame: 8 and 12 week ]
  4. Changes in triglyceride [ Time Frame: 8 and 12 week ]
  5. Changes in free fatty acid [ Time Frame: 8 and 12 week ]
  6. Changes in insulin resistance [ Time Frame: 8 and 12 week ]
  7. Changes in Body Mass Index (BMI) [ Time Frame: 8 and 12 week ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 19 and 75
  2. Non-alcoholic fatty liver disease patient

    • Diagnosed by abdomen ultrasonic examination
    • Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)
  3. ALT or AST higher than normal range (not over 4 times normal range)
  4. Voluntary agreement and enrollment

Exclusion Criteria:

  1. The ratio of AST/ALT over 2
  2. Type I diabetes mellitus patient
  3. Any dysfunction of liver besides non-alcoholic fatty liver disease
  4. Alcoholic fatty liver disease patient or heavy drinker
  5. Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
  6. Patient taking any product which affects the BMI or hyperlipidemia
  7. Any dyscrasia that investigator considers not to appropriate for this study
  8. Bariatric surgery within 6 months
  9. Any disease which is able to change the distribution of cytokines
  10. Any treatment that affects liver functions within 1 month
  11. Participation in other clinical trials within 3 months
  12. Person who can not use MRS
  13. Pregnancy or breast-feeding
  14. Fertile women who do not use contraception
  15. Sensitive to the investigational product
  16. Any conditions that the investigator considers not to appropriate for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02491905


Locations
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Korea, Republic of
Huons
Ansan, Kyeonggi-do, Korea, Republic of, 426791
Sponsors and Collaborators
Huons Co., Ltd.

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Responsible Party: Huons Co., Ltd.
ClinicalTrials.gov Identifier: NCT02491905     History of Changes
Other Study ID Numbers: 12-HS-HP-09-1
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: July 8, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases