Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies

July 19, 2020 updated by: TaiwanJ Pharmaceuticals Co., Ltd

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 from 5mg up to 40mg depending on the monthly response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2016

Primary Completion (Actual)

January 21, 2019

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

September 20, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 22, 2015

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKB-122AIH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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