Efficacy and Safety of Oltipraz in the Patients With Non-alcoholic Fatty Liver Disease
NCT ID: NCT01373554
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2011-05-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
30mig/bid or 60mg/bid P.O
Oltipraz
Oltipraz
30mig/bid or 60mg/bid P.O
Interventions
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Placebo
30mig/bid or 60mg/bid P.O
Oltipraz
30mig/bid or 60mg/bid P.O
Eligibility Criteria
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Inclusion Criteria
* Patients with non-alcoholic fatty liver disease
Exclusion Criteria
* Type 1 diabetes mellitus (insulin-dependent diabetes mellitus)
* Disorder in liver function with an exception of non-alcoholic fatty liver (e.g. Virus infection, biliary atresia, autoimmune hepatitis and etc.)
* Patients who have been taken drugs induced fatty liver for over 3 month within 1 year of participation in this study; amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, anabolic steroids, over usual dose of estrogen for hormone replacement therapy and valproate
* Patients who has been taken any medications that could affect the treatment for non-alcoholic steatohepatitis: insulin, insulin sensitizer(metformin, thiazolidinedione), high dose of vitamin E, high dose of UDCA, pentoxifylline, SAM-e, Betaine, types of Statin, types of fibrate and orlistat
* Patients who had a Bariatric surgery less than 6 month prior to the participation in the study
* Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
* Any history of immune disorder which affect the changes in cytokine:
inflammatory bowel disease, autoimmune thrombocytopenic purpura, system lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatic arthritis and etc
* Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
* Patient who has been administered other investigational product within 1 month prior to the participation in the study
* Patient who is not allowed to get MRS test: pacemaker, shunt and etc
* Pregnant or nursing women
* Patient who considered ineligible for participation in the study as Investigator's judgment
18 Years
75 Years
ALL
No
Sponsors
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PharmaKing
INDUSTRY
Responsible Party
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Principal Investigators
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YoonJun Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Inje University Ilsan Paik Hospital
Dahwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, South Korea
NHUS Ilsan Hospital
Ilsan-ro Ilsan-donggu, Goyang-si, South Korea
Seoul National University Hospital
Daehak-ro Jongno-gu, Seoul, South Korea
Korea University Guro hospital
Gurodong-ro, Seoul, South Korea
Boramae Hospital
Sindaebang-dong Dongjak-gu, Seoul, South Korea
Countries
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References
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Kim SG, Kim YM, Choi YH, Lee MG, Choi JY, Han JY, Cho SH, Jang JW, Um SH, Chon CY, Lee DH, Jang JJ, Yu ES, Lee YS. Pharmacokinetics of oltipraz and its major metabolite (RM) in patients with liver fibrosis or cirrhosis: relationship with suppression of circulating TGF-beta1. Clin Pharmacol Ther. 2010 Sep;88(3):360-8. doi: 10.1038/clpt.2010.89. Epub 2010 Jul 21.
Kim W, Kim BG, Lee JS, Lee CK, Yeon JE, Chang MS, Kim JH, Kim H, Yi S, Lee J, Cho JY, Kim SG, Lee JH, Kim YJ. Randomised clinical trial: the efficacy and safety of oltipraz, a liver X receptor alpha-inhibitory dithiolethione in patients with non-alcoholic fatty liver disease. Aliment Pharmacol Ther. 2017 Apr;45(8):1073-1083. doi: 10.1111/apt.13981. Epub 2017 Feb 22.
Related Links
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Other Identifiers
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PMK-N01GI1
Identifier Type: -
Identifier Source: org_study_id