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

NCT ID: NCT02556372

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-01-21

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 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.

Conditions

Autoimmune Hepatitis

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

JKB-122

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TaiwanJ Pharmaceuticals Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying-Chu Shih, PhD

Role: STUDY_DIRECTOR

TaiwanJ Pharmaceuticals

Locations

Ruane Clinical Research Group, Inc.

Los Angeles, California, United States

University of California Davis Medical Center - Ticon 1

Sacramento, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Florida Hepatology Research at CTRB

Gainesville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

Tulane University

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mount Sinai Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Methodist Dallas Medical Center

Dallas, Texas, United States

Advanced Liver Therapies, Baylor College of Medicine

Houston, Texas, United States

The Texas Liver Institute

San Antonio, Texas, United States

Taxes Liver Institute

San Antonio, Texas, United States

Swedish Medical Center - Organ Transplant and Liver Center

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35179437 (View on PubMed)

Other Identifiers

JKB-122AIH

Identifier Type: -

Identifier Source: org_study_id