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

This study is currently recruiting participants.

Verified September 2011 by NovImmune SA

Sponsor:

Information provided by (Responsible Party):

NovImmune SA

ClinicalTrials.gov Identifier:

NCT01430429

First received: September 5, 2011

Last updated: September 12, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 5, 2011

Last Updated Date

September 12, 2011

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01430429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Primary Biliary Cirrhosis

Intervention ^ICMJE

Drug: NI-0801

Study Arm (s)

Experimental: NI-0801

Intervention: Drug: NI-0801

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: NovImmune SA

+41 22 839 71 41

contact@novimmune.com

Location Countries ^ICMJE

Italy, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01430429

Other Study ID Numbers ^ICMJE

NI-0801-03

Has Data Monitoring Committee

Responsible Party

NovImmune SA

Study Sponsor ^ICMJE

NovImmune SA

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

NovImmune SA

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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