Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
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
1 other identifier
interventional
20
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2016
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedStudy Start
First participant enrolled
April 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2019
CompletedJuly 21, 2020
July 1, 2020
2.7 years
September 20, 2015
July 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
baseline and 24 weeks
Study Arms (1)
JKB-122
EXPERIMENTALAIH-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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Ruane Clinical Research Group, Inc.
Los Angeles, California, 90036, United States
University of California Davis Medical Center - Ticon 1
Sacramento, California, 95817, United States
California Pacific Medical Center
San Francisco, California, United States
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610-0272, United States
Northwestern University
Chicago, Illinois, 60611, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Tulane University
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
Advanced Liver Therapies, Baylor College of Medicine
Houston, Texas, 77030, United States
The Texas Liver Institute
San Antonio, Texas, 78215, United States
Taxes Liver Institute
San Antonio, Texas, United States
Swedish Medical Center - Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
University of Washington
Seattle, Washington, 98104, United States
Related Publications (1)
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.
PMID: 35179437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ying-Chu Shih, PhD
TaiwanJ Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Masking Details
- This is an open label study
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2015
First Posted
September 22, 2015
Study Start
April 30, 2016
Primary Completion
January 21, 2019
Study Completion
January 21, 2019
Last Updated
July 21, 2020
Record last verified: 2020-07