JKB-121 for the Treatment of Nonalcoholic Steatohepatitis
NCT ID: NCT02442687
Last Updated: 2019-01-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2015-08-01
2017-09-24
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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A
JKB 121, 5 mg twice daily
JKB-121: 5 mg twice daily
B
JKB 121, 10 mg twice daily
JKB-121: 10 mg twice daily
C
Identical appearing placebo
Placebo
Interventions
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JKB-121: 5 mg twice daily
JKB-121: 10 mg twice daily
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Provision of written informed consent
3. Biopsy-proven NASH within 12 months or at screening
4. ALT \> 40 U/L for women and \> 60 U/L for men at screening and at least once in the previous 12 months.
5. HBA1C of ≤ 9.0
Exclusion Criteria
2. Cirrhosis, as assessed clinically or histologically
3. Presence of vascular liver disease
4. BMI ≤ 25 kg/m2
5. Excessive alcohol use (\> 20 g/day) within the past 2 years
6. AST or ALT \> 250 U/L.
7. Type 1 diabetes mellitus
8. Bariatric surgery in the past 5 years.
9. Weight gain of \> 5% in past 6 months or \> 10% change in past 12 months.
10. Contraindication to MRI
11. Inadequate venous access
12. HIV antibody positive, hepatitis B surface antigen positive (HBsAg), or Hepatitis C virus (HCV) RNA positive.
13. Receiving an elemental diet or parenteral nutrition
14. Chronic pancreatitis or pancreatic insufficiency
15. Any history of complications of cirrhosis
16. Concurrent conditions:
* Inflammatory bowel disease
* Significant cardiac disease
* chronic infection or immune mediated disease
* Any malignant disease
* Prior solid organ transplant
* Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the subject participating or the interpretation of the study data.
17. Concurrent medications which may treat NASH
18. HbA1C \> 9.0%
19. Pregnancy or breastfeeding.
18 Years
ALL
No
Sponsors
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Manal Abdelmalek
OTHER
Responsible Party
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Manal Abdelmalek
Associate Professor
Principal Investigators
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Manal F Abdelmalek, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Digestive Disease Specialists of the Southeast
Dothan, Alabama, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Digestive Associates
Las Vegas, Nevada, United States
Duke University
Durham, North Carolina, United States
Digestive Disease Specialists
Cincinnati, Ohio, United States
Brook Army Medical Center
Houston, Texas, United States
University of Virginia Health Systems
Charlottesville, Virginia, United States
Medical College of Virginia
Richmond, Virginia, United States
Countries
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References
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Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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Pro00062677
Identifier Type: -
Identifier Source: org_study_id
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