Oltipraz for Liver Fat Reduction in Patients With Non-alcoholic Fatty Liver Disease Except for Liver Cirrhosis
NCT ID: NCT04142749
Last Updated: 2022-10-06
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
PHASE3
146 participants
INTERVENTIONAL
2019-11-15
2022-09-26
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
SINGLE
Study Groups
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Oltipraz
Oltipraz 30mg
Oltipraz
Total 90mg, By mouth, TID
Placebo
Placebo 30mg
Placebos
Total 90mg, By mouth, TID
Interventions
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Oltipraz
Total 90mg, By mouth, TID
Placebos
Total 90mg, By mouth, TID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with non-alcoholic fatty liver disease other than cirrhosis that meets all of the following criteria:
1. Abdominal ultrasonography of Screening indicates that the liver is brighter than the spleen or kidneys, causing suspected fatty liver
2. Persons with liver fat content is 20% or more on the MRS
3. Those who do not have significant alcohol intake within two years before screening (men: no more than 210 g per week; women: no more than 140 g per week)
4. Those who with an alcohol use disorder identification test (AUDIT) result point is no more than 7, during screening.
* Persons with body mass index (BMI) more than 23 kg/m2 during screening
* A person who satisfies the following laboratory test results when screening
1. Platelet ≥ 130,000/㎣
2. White blood cell (WBC) ≥ 3,000/㎣
3. Absolute neutrophil count (ANC) ≥ 1,500/㎣
4. Albumin ≥ 3.5 g/dL
5. Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
6. ULN \< Alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 250 IU/L
* A person who is willing to maintain the same lifestyle (exercise, alcohol intake, diet, etc.) maintained for at least four weeks before screening during the clinical trial period.
* A person who voluntarily agrees to participate in this clinical trial
Exclusion Criteria
1. Malignant tumour with liver cancer
2. Malignant tumor excluding liver cancer, However, registration is possible in the following cases
1. If the investigator determines that the patient has been completely cured after maintaining the condition for at least five years
2. In case of basal cell or squamous cell carcinoma of the skin, the patient is able to maintain a complete condition for more than three years in the case of cainoma in the cervix (CIN) and carcinema in situ (CIS), and other areas.
3. autoimmune disease (e.g., inflammatory bowel disease, autoimmune hemolytic disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, severe psoriasis, etc.)
4. Bariatric surgery within 24 weeks before screening
* A Person who has comorbidity of the following diseases at the time of screening
1. Liver cirrhosis identified by an epidemiological or histological examination
2. Cumulative disease (e.g., alcohol liver disease, toxic hepatitis, autoimmune liver disease, metabolic liver disease, biliary closure, etc.) that may indicates liver abnormalities other than non-alcoholic fatty liver disease
3. A Person who has been infected or has Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
4. Type 1 diabetes or type 2 diabetes (hemoglobin A1c (HbA1c) \> 9%)
5. A person who has positive result of Human immunodeficiency virus antibody (HIV Ab).
6. A persons with conditions that may affect the effectiveness and safety by investigator
* A person with AST/ALT ratio of more than 2 at screening
* The person who has the following medication history
1. Persons administered vitamin E (≥ 800 IU/day) or thiazolidatedione drugs or glucagon-like peptide-1 (GLP-1) agonist drugs within 12 weeks prior to screening
2. Persons who were given antiobestic drug within 12 weeks of screening For example; antiobestic drug with Central nervous system action: Amfepramone, bupropion and naltrexone, cathine, clobenzorex, dexfenfluramine, ephedrine combinations, etilamfetamine, fenfluramine, lorcaserin, mazindol, mefenorex, phentermine, sibutramine, Peripheral neurotic Obesity drugs: Orlistat, Rimonabant, etc
3. A person who received medications that could cause fatty liver disease within 8 weeks prior to screening For example; Administration of systemic glucocorticoids for more than two weeks Anabolic steroid-based drug, Estrogen-based drug, Azole-based antimicrobial agent, Nucleoside, Nucleotide reverse transcriptase inhibitor-based drug, Tetracycline-based drug, Amiodarone, tamoxifen, methotrexate, valproic acid, etc
4. A person who administered drugs that may affect the progress of non-alcoholic fatty liver disease within 4 weeks prior to screening or who require administration during clinical trials For example; Silymarin, biphenyl dimethyl dicarboxylate (DDB), ursodeoxycholic acid (UDCA), S-adenosyl-L-methionine (SAMe), betaine, pentoxyfylline, sodium-glucose cotransporter-2 (SGLT-2) inhibitor, omega 3 fatty acid, etc.
1. However, the following drugs can be registered if they are under stable dosage for at least 12 weeks and are expected to remain unchanged during clinical trials; Sulfonylurea-based drug, metformin, insulin, dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor), a-glucosidase inhibitor (a-GI), meglitinide-based drug, statin-based drug, fibrate-based drug, nicotinic acid, ezetimibe, beta-blockers based drug, thiazide based drug
* A person who receive non-drug treatment that may affect the liver within 4 weeks prior to screening.
* A person who administered/treated with other clinical trials/medical devices within 4 weeks prior to screening
* Those who are not able to MRS(I)
* A female who is pregnant, may be pregnant, or is lactating
* A person who is not willing to use appropriate contraceptives during this clinical trial.
* A person who is hypersensitive to the Investigational Product
* A person who is deemed ineligible for clinical trials by the investigator
19 Years
75 Years
ALL
No
Sponsors
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PharmaKing
INDUSTRY
Responsible Party
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Principal Investigators
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Yun-Jun Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul Nat'l Uni. Hospital
Changuk Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Gapjin Chun, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Gangneung Asan Medical Center
Taehui Lee, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Kunyang University Hospital
Byeongguk Jang, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Keimyung University Dongsan Medical Center
Yanghyeon Baek, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Dong-A University Hospital
Byeonggwan Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Boramae Hospital
Yeongseok Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital
Jaeyeong Chang, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Soonchunhyang University Hospital
Jaeyeong Jung, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Hyeonung Lee, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University Gangnam Severance Hospital
Doyeong Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Munyeong Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Wonju Severance Christian Hospital
Junseong Lee, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Inje University Ilsan Baek Hospital
Jinu Lee, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Hyeongjun Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Sanghun Park, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Hallym University Gangnam Sungsim Hospital
Daewon Jun, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Chun Kyun Lee, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
National Health Insurance Service Ilsan Hospital
Jaeyun Jung, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
National medical center
Jihun Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Huieon Kim, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic University Bucheon ST. Mary's Hospital
Locations
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Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
Inha University Hospital
Incheon, Junggu, South Korea
Catholic University Bucheon ST. Mary's Hospital
Bucheon-si, , South Korea
Soonchunhyang University Bucheon Hospital
Bucheon-si, , South Korea
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Gangneung Asan Medical Center
Gangneung-si, , South Korea
NHUS Ilsan Hospital
Goyang-si, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Boramae Hospital
Seoul, , South Korea
Chung-Ang University Hosptial
Seoul, , South Korea
Hallym University Gangnam Sungsim Hospital
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Yonsei University Gangnam Severance Hospital
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Wonju Severance Christian Hospital
Wanju, , South Korea
Countries
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Other Identifiers
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PMK-N01GI1-P3
Identifier Type: -
Identifier Source: org_study_id
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