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

Autoimmune Hepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556372
• Other study ID #: JKB-122AIH
• Status: Completed
• Phase: Phase 2
• Start date: April 30, 2016
• Est. completion date: January 21, 2019

Study information

• Verified date: July 2020
• Source: TaiwanJ Pharmaceuticals Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

Drug:
• JKB-122
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Methodist Dallas Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida Hepatology Research at CTRB	Gainesville	Florida
United States	Advanced Liver Therapies, Baylor College of Medicine	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Ruane Clinical Research Group, Inc.	Los Angeles	California
United States	Tulane University	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	University of California Davis Medical Center - Ticon 1	Sacramento	California
United States	Taxes Liver Institute	San Antonio	Texas
United States	The Texas Liver Institute	San Antonio	Texas
United States	California Pacific Medical Center	San Francisco	California
United States	Swedish Medical Center - Organ Transplant and Liver Center	Seattle	Washington
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
TaiwanJ Pharmaceuticals Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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