Clinical Trials List
2015-06-01 - 2018-09-30
Phase II
Terminated7
ICD-10K76.0
Fatty (change of) liver, not elsewhere classified
ICD-9571.8
Other chronic nonalcoholic liver disease
A Phase 2, randomized, multiple-dose, double-blind, placebo-controlled study of JKB-122 in treating subjects with non-alcoholic fatty liver disease (NAFLD)
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Trial Applicant
TaiwanJ Pharmaceuticals Co., Ltd
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Sponsor
TaiwanJ Pharmaceuticals
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
3 Completed
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
31 Completed
Audit
CRO
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
treatment at the end of the 12-week treatment period. The ALT value obtained at visit 4
at the end-of-treatment visit (after completion of the 12-week treatment period) will be
used. The subject will be considered a responder if reduction of hepatic steatosis by
imaging studies along with the percent change from Baseline for average ALT is either a
30% or more decrease, or if the average ALT value is within the normal range.
Secondary efficacy endpoints will include the change of fatty liver content to be
evaluated by sonography and MRS, and visceral fat content by CT from Baseline at the
end of the 12-week treatment period and changes in biomarkers from Baseline including
TNF-α, TGF-β, Cytokeratin-18 (cCK18), Adiponetin, Resistin, hyaluronic acid, TIMP-1,
and PIIINP.
Inclution Criteria
Each subject must meet the following criteria to be enrolled in the study:
1. Is male or female, 20 years to 65 years of age.
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 fatty liver disease (NAFLD), defined as (i) there is
evidence of hepatic steatosis, either by imaging or by histology and (ii) there are no
causes for secondary hepatic fat accumulation such as significant alcohol
consumption, use of steatogenic medication, or hereditary disorders.
4. Has evelated liver test resutls (ALT) between 1.5x to 5 x ULN 7 days before
screening, despite of life style adjustment, such as diet control or exercise.
5. Has elevated liver test results (ALT) at least 1.5x ULN and not exceeding 5x ULN
plus AST/ALT ratio less than 1 at screening.
6. Compensated liver disease with the following hematologic, biochemical, and
serological criteria on entry into protocol:
o Hemoglobin > 11 gm/dL for females and > 12 gm/dL for males
o White blood cell (WBC) > 2.5 K/UL
o Neutrophil count > 1.5 K/UL
o Platelets > 100 K/UL
o Direct bilirubin, within normal limits
o Indirect bilirubin within normal limits (unless nonhepatitis factors such as
Gilbert's disease explain indirect bilirubin rise. In such cases total bilirubin
must be < 3.0 mg/dL)
o Albumin > 3.2 g/dL
7. Subjects taking lipid lowering agents should keep their dose stable during the study.
8. Is opioid-free for at least 10 days prior to the screening visit (Day –7).
9. 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.
10. Agrees to comply with protocol requirements.
Exclusion Criteria
Subjects meeting any of the following criteria will be excluded from the study:
1. Has history of allergy to naltrexone or related compounds
2. Has human immunodeficiency virus (HIV) or is hepatitis B or C positive
3. Has history of opioid abuse
4. Has history of liver cirrhosis
5. Has history of diabetes
6. Binge drinking as drinking 5 or more alcoholic drinks on the same occasion on at
least 1 day in the past 30 days.
7. Significant alcohol consumption be defined as >21 drinks per week in men and >14
drinks per week in women over a 6 months prior to screening visit. A standard drink
was equivalent to 0.6 gm of absolute alcohol (e.g., 12-oz beer, 5-oz wine, or 1.5-oz,
80-proof liquor).
8. Is being treated with any prescription narcotic drug (including transdermal delivery
systems)
9. Has a known or suspected central nervous system disorder that may predispose to
seizures or lower the seizure threshold
10. Has unstable and uncontrollable hypertension (>180/110 mmHg)
11. Has received other therapies for NAFLD in the last 4 weeks prior to the screening
visit (Day –7)
12. Requires concomitant use of or treatment with opioids or other excluded drugs such
as hepatotoxic medications
13. Has received other investigational agents within 30 days prior to the screening visit
(Day –7)
14. Has a disease that would require chronic use of prescription corticosteroids
15. Has either autoimmune or genetic liver disease.
16. Alpha- fetoprotein greater than 20 mcg/L
17. Has impaired renal function (i.e. serum creatinine > 1.5XULN or serum creatinine >
2mg/dl)
18. Has BMI> 35 or BMI <18.5
19. Subjects who gained or lost weight greater than 5 kg in the past 3 months.
The Estimated Number of Participants
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Taiwan
120 participants
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Global
0 participants
