Clinical Trial: Liver Test Study of Using JKB-122 in AIH Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary:

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.


Sponsor: TaiwanJ Pharmaceuticals Co., Ltd

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: TaiwanJ Pharmaceuticals Co., Ltd

Dates:
Date Received: September 20, 2015
Date Started: February 2016
Date Completion: May 2018
Last Updated: March 7, 2017
Last Verified: March 2017