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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01430429
Recruitment Status : Terminated
First Posted : September 8, 2011
Last Update Posted : April 4, 2014
Information provided by (Responsible Party):
NovImmune SA

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.

Condition or disease Intervention/treatment Phase
Primary Biliary Cirrhosis Drug: NI-0801 Phase 2

Study Type : Interventional  (Clinical Trial)
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

Arm Intervention/treatment
Experimental: NI-0801 Drug: NI-0801

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: June 2012

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