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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
NovImmune SA
ClinicalTrials.gov Identifier:
NCT01430429
First received: September 5, 2011
Last updated: April 3, 2014
Last verified: June 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430429

Locations
Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089
United Kingdom
NIHR Liver Biomedical Research Unit, Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
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: April 3, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ethics Committee

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Cholestasis
Cholestasis, Intrahepatic
Digestive System Diseases
Liver Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014