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

Status: Completed
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
California
Ruane Clinical Research Group, Inc.
Los Angeles
University of California Davis Medical Center - Ticon 1
Sacramento
California Pacific Medical Center
San Francisco
Florida
University of Florida Hepatology Research at CTRB
Gainesville
Illinois
Northwestern University
Chicago
Indiana
Indiana University School of Medicine
Indianapolis
Louisiana
Tulane University
New Orleans
Massachusetts
Massachusetts General Hospital
Boston
North Carolina
Duke University Medical Center
Durham
New York
Mount Sinai Hospital
New York
Texas
Methodist Dallas Medical Center
Dallas
Advanced Liver Therapies, Baylor College of Medicine
Houston
Taxes Liver Institute
San Antonio
The Texas Liver Institute
San Antonio
Washington
Swedish Medical Center - Organ Transplant and Liver Center
Seattle
University of Washington
Seattle
Time Frame
Start Date: April 30, 2016
Completion Date: January 21, 2019
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: TaiwanJ Pharmaceuticals Co., Ltd

This content was sourced from clinicaltrials.gov

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