Liver Test Study of Using JKB-122 in AIH Patients

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Brief Title

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

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes in ALT in AIH subjects given daily doses of JKB-122


Condition

Autoimmune Hepatitis

Intervention

JKB-122

Study Arms / Comparison Groups

 JKB-122
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

April 30, 2016

Completion Date

January 21, 2019

Primary Completion Date

January 21, 2019

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ying-Chu Shih, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02556372

Organization ID

JKB-122AIH


Responsible Party

Sponsor

Study Sponsor

TaiwanJ Pharmaceuticals Co., Ltd


Study Sponsor

Ying-Chu Shih, PhD, Study Director, TaiwanJ Pharmaceuticals


Verification Date

July 2020