Primary Biliary Cirrhosis: Investigating A New Treatment Option using NI 0801, a fully human 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 primary biliary cirrhosis patients with an incomplete response to ursodeoxycholic acid. - PIANO

OVIMMUNE BV0 sites40 target enrollmentJanuary 19, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: - History of increased ALP levels for at least 6 months - Positive serum AMA titer (>1:40) - Liver biopsy consistent with PBC Patient should be on incomplete response to UDCA
Sponsor: OVIMMUNE BV
Enrollment: 40
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

January 19, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

OVIMMUNE BV

•1\. Male or female, 18 years or older 2\. Proven PBC, as demonstrated by the presence of at least 2 of the following 3 diagnostic factors: \- History of increased ALP levels for at least 6 months \- Positive serum AMA titer (\>1:40\) \- Liver biopsy consistent with PBC 3\. Incomplete response to UDCA defined as failure to normalise ALP levels or to reduce ALP levels by more than 40% after 1 year of therapy with UDCA according to the local recommended dose. 4\. Stable dose of UDCA for at least 6 months prior to screening 5\. Screening ALP \> 1\.5 ULN 6\. Screening ALT or AST \> 1\.5 ULN 7\. Female patients must be postmenopausal, surgically sterile, or willing to use 2 methods of effective contraception with all sexual partners until 3 months after having received the last dose of study medication 8\. Male patients who agree to take the appropriate precautions to avoid fathering a child until 3 months after having received the last dose of study medication 9\. Have given written informed consent 10\. Patients must be able to adhere to the study visits and protocol requirements
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 80
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•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