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

April 3, 2014 updated by: Light Chain Bioscience - Novimmune SA

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rozzano, Italy, 20089
        • IRCCS Istituto Clinico Humanitas
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NI-0801
Drug: NI-0801

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Chain Bioscience - Novimmune SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 5, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2014

Last Update Submitted That Met QC Criteria

April 3, 2014

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI-0801-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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