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

Primary Biliary Cirrhosis Clinical Trial

— PIANO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01430429
• Other study ID #: NI-0801-03
• Status: Terminated
• Phase: Phase 2
• First received: September 5, 2011
• Last updated: April 3, 2014

Study information

• Verified date: June 2012
• Source: NovImmune SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Primary Biliary Cirrhosis

Intervention

Drug:
• NI-0801

Locations

Country	Name	City	State
Italy	IRCCS Istituto Clinico Humanitas	Rozzano
United Kingdom	NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
NovImmune SA

Countries where clinical trial is conducted

Italy,  United Kingdom,