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

Phase 2

Terminated

• Conditions: Primary Biliary Cirrhosis
• Interventions: Drug: NI-0801

• Registration Number: NCT01430429
• Lead Sponsor: Light Chain Bioscience - 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-05
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Status Verified: 2012-06
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NI-0801	NI-0801	-

Trial Locations

Locations (2)

NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

IRCCS Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy