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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovImmune SA
• Treatments: Antibodies; Antibodies, Monoclonal; Ursodeoxycholic Acid

Criteria

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