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Primary Biliary Cirrhosis: Investigating A New Treatment Option Using NI-0801, an Anti-CXCL10 Monoclonal Antibody (PIANO)

This study has been terminated.
Information provided by (Responsible Party):
NovImmune SA Identifier:
First received: September 5, 2011
Last updated: April 3, 2014
Last verified: June 2012
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.

Condition Intervention Phase
Primary Biliary Cirrhosis Drug: NI-0801 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by NovImmune SA:

Arms Assigned Interventions
Experimental: NI-0801 Drug: NI-0801


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01430429

IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
United Kingdom
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
NovImmune SA
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: NovImmune SA Identifier: NCT01430429     History of Changes
Other Study ID Numbers: NI-0801-03
Study First Received: September 5, 2011
Last Updated: April 3, 2014

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Antibodies, Monoclonal
Ursodeoxycholic Acid
Immunologic Factors
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents processed this record on September 19, 2017