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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01430429 |
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Date of registration:
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05/09/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody
PIANO |
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Scientific title:
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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 |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01430429 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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Phase 2
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Countries of recruitment
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Italy
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United Kingdom
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Primary Biliary Cirrhosis
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Intervention(s)
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Drug: NI-0801
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Secondary ID(s)
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NI-0801-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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