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

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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01430429
Acronym
PIANO
Enrollment
Unknown
Registered
2011-09-08
Start date
Unknown
Completion date
Unknown
Last updated
2014-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cirrhosis

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.

Interventions

DRUGNI-0801

Sponsors

Light Chain Bioscience - Novimmune SA
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

Italy, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026