A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
NCT ID: NCT04255069
Last Updated: 2020-02-13
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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UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2020-06-30
2023-12-31
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, oral, daily
Placebo
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 1
JKB-122, Dose 1, oral, daily
Dose 1 JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 2
JKB-122, Dose 2, oral, daily
Dose 2 JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Interventions
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Placebo
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 1 JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 2 JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control (e.g., oral contraceptives, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy plus a barrier method).
3. Is diagnosed with non-alcoholic steatohepatitis (NASH) NAS \>4.0
4. Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
5. Subjects taking lipid lowering agents should keep their dose stable during the study.
6. Stable use of insulin sensitizing agents (PPARs, SGLT2 inhibitors, or GLP-1 agonists for 6 months prior to screening liver biopsy).
7. Is capable of understanding and signing the informed consent document. If subject is unable to sign the informed consent form, then the subject's legal representative or guardian may provide written consent per local regulations.
8. Agrees to comply with protocol requirements.
Exclusion Criteria
2. Has history of liver cirrhosis.
3. Has glycated hemoglobin (HbA1c ) greater than 9%.
4. Binge drinking as drinking 5 or more alcoholic drinks
5. Significant alcohol consumption
6. Is being treated with any prescription narcotic drug (including transdermal delivery systems).
7. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold.
8. Has unstable and uncontrollable hypertension (\>180/110 mmHg).
9. Has received other therapies for NAFLD in the last 4 weeks prior to the screening visit (Day -7).
10. Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications.
11. Has received other investigational agents within 30 days prior to the screening visit (Day -7).
12. Has either autoimmune or genetic liver disease.
13. Alpha- fetoprotein greater than 20 mcg/L. Has impaired renal function (i.e. serum creatinine CLcr \< 60 mL/min).
14. Subjects who gained or lost weight greater than 5 kg in the past 3 months.
15. Any form of chronic liver disease other than NASH
16. Suspected or confirmed cirrhosis. -
18 Years
70 Years
ALL
No
Sponsors
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TaiwanJ Pharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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TWJ-NAF
Identifier Type: -
Identifier Source: org_study_id
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