This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by TaiwanJ Pharmaceuticals Co., Ltd
Sponsor:
Information provided by (Responsible Party):
TaiwanJ Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier:
NCT02556372
First received: September 20, 2015
Last updated: March 7, 2017
Last verified: March 2017
September 20, 2015
March 7, 2017
February 2016
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02556372 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Liver Test Study of Using JKB-122 in AIH Patients
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Autoimmune Hepatitis
Drug: JKB-122
Orally administered capsules of JKB-122 which will be taken once daily with dose escalation
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
Intervention: Drug: JKB-122
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2018
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jason Lai, Ph.D. +88636587721 ext 311 jasonlai@taiwanj.com
United States
 
 
NCT02556372
JKB-122AIH
No
Not Provided
Not Provided
TaiwanJ Pharmaceuticals Co., Ltd
TaiwanJ Pharmaceuticals Co., Ltd
Not Provided
Not Provided
TaiwanJ Pharmaceuticals Co., Ltd
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP