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

This study is currently recruiting participants.
Verified September 2011 by NovImmune SA
Sponsor:
Information provided by (Responsible Party):
NovImmune SA
ClinicalTrials.gov Identifier:
NCT01430429
First received: September 5, 2011
Last updated: September 12, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Primary Biliary Cirrhosis
 Drug: NI-0801
 Phase 2

Study Type: Interventional
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by NovImmune SA:

Arms Assigned Interventions
Experimental: NI-0801 Drug: NI-0801

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430429

Contacts
Contact: NovImmune SA +41 22 839 71 41 contact@novimmune.com

Locations
Italy
IRCCS Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Principal Investigator: Pietro Invernizzi, MD            
United Kingdom
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: David Adams, MD            
Sponsors and Collaborators
NovImmune SA
  More Information

No publications provided

Responsible Party: NovImmune SA
ClinicalTrials.gov Identifier: NCT01430429     History of Changes
Other Study ID Numbers: NI-0801-03
Study First Received: September 5, 2011
Last Updated: September 12, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee

Additional relevant MeSH terms:
Liver Cirrhosis, Biliary
Liver Cirrhosis
Fibrosis
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Liver Diseases
 Pathologic Processes
Antibodies, Monoclonal
Ursodeoxycholic Acid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013