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

Primary Purpose

Autoimmune Hepatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
JKB-122
Sponsored by
TaiwanJ Pharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis focused on measuring AIH, JKB-122, autoimmune, hepatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruane Clinical Research Group, Inc.
  • University of California Davis Medical Center - Ticon 1
  • California Pacific Medical Center
  • University of Florida Hepatology Research at CTRB
  • Northwestern University
  • Indiana University School of Medicine
  • Tulane University
  • Massachusetts General Hospital
  • Mount Sinai Hospital
  • Duke University Medical Center
  • Methodist Dallas Medical Center
  • Advanced Liver Therapies, Baylor College of Medicine
  • The Texas Liver Institute
  • Taxes Liver Institute
  • Swedish Medical Center - Organ Transplant and Liver Center
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

JKB-122

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 20, 2015
Last Updated
July 19, 2020
Sponsor
TaiwanJ Pharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02556372
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 30, 2016 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TaiwanJ Pharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis
Keywords
AIH, JKB-122, autoimmune, hepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
The patient takes 5mg up to 40mg depending on the monthly response.
Masking
None (Open Label)
Masking Description
This is an open label study
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
JKB-122
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
JKB-122
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in ALT in AIH subjects given daily doses of JKB-122
Description
To assess changes in ALT in AIH subjects given daily doses of JKB-122
Time Frame
baseline and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Chu Shih, PhD
Organizational Affiliation
TaiwanJ Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ruane Clinical Research Group, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
University of California Davis Medical Center - Ticon 1
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
University of Florida Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0272
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Advanced Liver Therapies, Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Taxes Liver Institute
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Swedish Medical Center - Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35179437
Citation
Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.
Results Reference
derived

Learn more about this trial

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

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