Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
PIANO
An Open Label Single Arm Study to Investigate the Safety and Efficacy of Multiple Administrations of NI-0801, a Fully Human Anti-CXCL10 Monoclonal Antibody in PBC Patients With an Incomplete Response to Ursodeoxycholic Acid
1 other identifier
interventional
N/A
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2011
CompletedFirst Posted
Study publicly available on registry
September 8, 2011
CompletedApril 4, 2014
June 1, 2012
September 5, 2011
April 3, 2014
Conditions
Study Arms (1)
NI-0801
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IRCCS Istituto Clinico Humanitas
Rozzano, 20089, Italy
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
Related Publications (1)
Mousa HS, Lleo A, Invernizzi P, Bowlus CL, Gershwin ME. Advances in pharmacotherapy for primary biliary cirrhosis. Expert Opin Pharmacother. 2015 Apr;16(5):633-43. doi: 10.1517/14656566.2015.998650. Epub 2014 Dec 29.
PMID: 25543678DERIVED