Status:
TERMINATED
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
Lead Sponsor:
Light Chain Bioscience - Novimmune SA
Conditions:
Primary Biliary Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
Eligibility Criteria
Inclusion
- Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
- Elevated liver enzyme levels at screening
- Have given written informed consent
Exclusion
- Screening bilirubin \> 2.9 mg/dL (50 μmol/L)
- Screening creatinine clearance \< 80 ml/min
- History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
- Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
- Known or previous diagnosis of malignancy
- Presence of any active infection
- Previous history of active TB within 12 months of screening
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01430429
Last Update
April 4 2014
Active Locations (2)
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1
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
2
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH