Back to resultsPrimary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody (PIANO)
Primary Purpose
Primary Biliary Cirrhosis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NI-0801
Sponsored by
About this trial
This is an interventional trial for Primary Biliary Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- IRCCS Istituto Clinico Humanitas
- NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NI-0801
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01430429
First Posted
September 5, 2011
Last Updated
April 3, 2014
Sponsor
Light Chain Bioscience - Novimmune SA
1. Study Identification
Unique Protocol Identification Number
NCT01430429
Brief Title
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
Acronym
PIANO
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Light Chain Bioscience - Novimmune SA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
NI-0801
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NI-0801
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
IRCCS Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25543678
Citation
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.
Results Reference
derived
Learn more about this trial
Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
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