PIANO. 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 S.A.0 个研究点开始时间: 2011年3月24日最近更新: 2012年11月5日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 35
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•1. Screening bilirubin > 2.9 mg/dL (50 µmol/L)
•2. Screening creatinine clearance < 80 ml/min
•3. History or presence of hepatic decompensation
•4. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV), primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease (AIH) and biopsy proven nonalcoholic steatohepatitis (NASH)
•5. Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
•6. Average alcohol ingestion >21 units/week (male) / >14 units/week (female)
•7. Have received any immunosuppressants, steroids or peroxisome proliferator activation receptor (PPAR) activators at any time during the 3 months prior to screening for the study
•8. Known or previous diagnosis of malignancy
•9. Presence of any active infection
•10. Presence or history of multiple allergic reactions to drugs
•11. Previous history of active TB within 12 months of screening
•12. Pregnant or breastfeeding women
•13. Have received or plan to receive any vaccines within 6 weeks prior to receiving study drug and throughout the study period

发起方

ovImmune S.A.