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Liver Test Study of Using JKB-122 in AIH Patients (JKB-122AIH)

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ClinicalTrials.gov Identifier: NCT02556372
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
TaiwanJ Pharmaceuticals Co., Ltd

Brief Summary:
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: JKB-122 Phase 2

Detailed Description:

This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks to subjects with AIH who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to or unwilling to take current immunosuppressant therapies. Current immunosuppressant therapy is defined as prednisone or other steroids with or without azathioprine. Failed response is defined as being non-responsive to or worsening in symptoms (elevated Alanine Aminotransferase (ALT)/aspartate aminotransferase (AST) and/or total bilirubin) despite compliance with the standard of care (SOC) over a 6 months period. Incomplete response is defined as lack of a sustained normalization of elevated ALT/AST to current standard of care (SOC) for at least 6 months. "Refractory" to the current therapy includes patients who had a failed response to, or incomplete response to the current therapy.

Subjects will be at least 18 years of age, either male or female and will have been on therapy for AIH and have not had a normalization of ALT with the current therapy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
Study Start Date : February 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JKB-122
AIH-positive subjects (n=20) who are intolerant, refractory, ineligible or unwilling to take current therapies, and have liver enzymes that are 2 to 10 times the upper limit of normal
Drug: JKB-122
Orally administered capsules of JKB-122 which will be taken once daily with dose escalation




Primary Outcome Measures :
  1. Changes in ALT in AIH subjects given daily doses of JKB-122 [ Time Frame: baseline and 24 weeks ]
    To assess changes in ALT in AIH subjects given daily doses of JKB-122



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has definite or probable AIH diagnosis.
  • Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:

    • Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results
    • ALT and AST values not exceeding 10x ULN
    • Normal bilirubin and prothrombin time (PT/INR)
  • Has elevated liver test results (ALT) at least 1.25 x ULN and not exceeding 10 x ULN at baseline.
  • Has had a failed response, incomplete response, intolerant, ineligible or unwilling to take current immunosuppressive therapies. Current immunosuppressive therapy is defined as prednisone or other steroids with or without azathioprine.

Exclusion Criteria:

  • Has history of allergy to JKB-122 or related compounds
  • Has human immunodeficiency virus (HIV) or is hepatitis B virus or hepatitis C virus (HCV) positive
  • Has positive urine drug screen at Screening
  • Has been diagnosed with other overlapping liver diseases such as primary biliary cirrhosis (PBC) or primary sclerosing cholangitis (PSC)
  • Is currently consuming alcoholic drinks greater than 25g/day and within 3 months prior to the first screening visit.
  • Is being treated with any prescription narcotic drug (including transdermal delivery systems)
  • Concurrent medications within 30 days prior to screening:

    • Opioids
    • Thioridazine
    • Silymarin and related medications
    • Potentially hepatotoxic drugs
  • Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
  • Has unstable and uncontrollable hypertension (>180/110 mmHg) or a blood pressure reading at baseline of 150/90 mmHg on 2 occasions separated by a 30 minute interval
  • Is currently receiving dietary supplements other than a multivitamin to treat AIH
  • Has received other investigational agents within 90 days prior to the first screening visit
  • Has impaired renal function
  • Has malignancy.
  • If female, pregnant or lactating
  • Has history of gastroesophageal varices, ascites, hepatic encephalopathy, hepatocellular carcinoma, and s/p liver transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556372


Locations
United States, California
Ruane Clinical Research Group, Inc.
Los Angeles, California, United States, 90036
University of California Davis Medical Center - Ticon 1
Sacramento, California, United States, 95817
California Pacific Medical Center
San Francisco, California, United States
United States, Florida
University of Florida Hepatology Research at CTRB
Gainesville, Florida, United States, 32610-0272
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Advanced Liver Therapies, Baylor College of Medicine
Houston, Texas, United States, 77030
The Texas Liver Institute
San Antonio, Texas, United States, 78215
Taxes Liver Institute
San Antonio, Texas, United States
United States, Washington
Swedish Medical Center - Organ Transplant and Liver Center
Seattle, Washington, United States, 98104
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
TaiwanJ Pharmaceuticals Co., Ltd

Responsible Party: TaiwanJ Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT02556372     History of Changes
Other Study ID Numbers: JKB-122AIH
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

Keywords provided by TaiwanJ Pharmaceuticals Co., Ltd:
AIH
JKB-122
autoimmune
hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases