A Study of Efficacy and Safety of Ustekinumab in Patients with Primary Biliary Cirrhosis (PBC) Who had an Inadequate Response to Ursodeoxycholic Acid

Phase 1

• Conditions: Primary Biliary Cirrhosis; MedDRA version: 14.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-000554-31-GB
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-12
• Study Completion: 2013-06-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Have proven or are likely to have PBC; Be on a stable dose of ursodeoxycholic acid for at least 6 months prior to Week 0;Have screening ALP level > 1.67 ULN; Have screening laboratory test results within protocol-specified limits; Have no history of latent or active TB prior to screening and no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
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 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

Has history of gastrointestinal bleeding, secondary to portal hypertension, hepatic encephalopathy, or ascites requiring treatment with diuretics; Has a screening direct bilirubin > 1.0 mg/dL; Has a previous liver histology with a diagnosis of steatohepatitis or has a high risk of nonalcoholic steatohepatitis; Has a previous liver histology with a diagnosis of chronic autoimmune hepatitis or has a high risk of autoimmune hepatitis overlap syndrome; Testing positive for surface antigen (HBsAg+), regardless of the results of other hepatitis B tests; Have used colchicine, methotrexate (MTX), azathioprine (AZA), or systemic corticosteroids within 3 months prior to the first administration of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified