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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02556372
• Date of registration: 20/09/2015
• Prospective Registration: Yes
• Primary sponsor: TaiwanJ Pharmaceuticals Co., Ltd
• Public title: Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
• Scientific 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
• Date of first enrolment: April 30, 2016
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02556372
• Study type: Interventional
• Study design: Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ying-Chu Shih, PhD
• Affiliation: TaiwanJ Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Hepatitis

Intervention(s)

Drug: JKB-122

Primary Outcome(s)

Changes in ALT in AIH subjects given daily doses of JKB-122 [Time Frame: baseline and 24 weeks]

Secondary ID(s)

JKB-122AIH

Source(s) of Monetary Support

Please refer to primary and secondary sponsors