Clinical Trials Logo
  1. Home
  2. Primary Sclerosing Cholangitis
  3. NCT02239211

A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis — BUTEO  

Primary Sclerosing Cholangitis Clinical Trial

Official title:
A Single Arm, Two-stage, Multi-centre, Phase II Clinical Trial Investigating the Safety and Activity of the Use of BTT1023 Targeting Vascular Adhesion Protein (VAP-1), in the Treatment of Patients With Primary Sclerosing Cholangitis (PSC).

Clinical Trial Summary

This is a phase II study to determine the safety and preliminary efficacy of a human monoclonal antibody (BTT1023) which targets the vascular adhesion protein (VAP-1) and its use in the treatment of patients with primary sclerosing cholangitis (PSC).

Clinical Trial Description

Primary sclerosing cholangitis is a progressive immune mediated biliary disease characterised by bile duct inflammation and fibrosis, and accompanying hepatic fibrosis. For patients with elevated alkaline phosphatase (ALP) in particular, progressive disease is predicted, that currently results in a need for liver transplantation in the majority. No current medical therapy has as yet been shown to be effective in altering the natural history of disease. For this reason patients with PSC with elevated ALP values will be recruited to this study, to evaluate the impact of Vap-1 blockade by BTT1023, in an early phase study focused on biochemical efficacy and safety.

This is an early phase study of BTT1023 in immune mediated liver disease, with the rationale to identify biochemical efficacy of effect (reduction in ALP) and safety, in an orphan disease indication for PSC that presently lacks any other medical therapy. The study design therefore focuses on identifying early biochemical efficacy signals to justify larger scale, randomised controlled studies over longer duration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02239211
Study type Interventional
Source University of Birmingham
Contact
Status Completed
Phase Phase 2
Start date September 8, 2015
Completion date October 23, 2018
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT03216876 - A Study Of Ursolic Acid For Primary Sclerosing Cholangitis Phase 1
Recruiting NCT02605213 - Effect and Safety of Oral Vancomycin in Primary Sclerosing Cholangitis Patients Phase 4
Recruiting NCT01688024 - Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis Phase 2
Completed NCT03041662 - Surveillance Study for Early Detection of Cholangiocarcinoma (CCA) in Primary Sclerosing Cholangitis (PSC)
Completed NCT05866809 - Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis Phase 2
Recruiting NCT05618145 - National Database on Primary Sclerosing Cholangitis (PSC)
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT02247934 - Development of a Patient-Reported Outcome Measure to Assess Symptoms in Patients With Primary Sclerosing Cholangitis (PSC) N/A
Terminated NCT01142323 - Pilot Study of Fenofibrate for PSC Phase 1/Phase 2
Completed NCT01088607 - Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis Phase 1
Terminated NCT04060147 - Safety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis Phase 1
Recruiting NCT04133792 - Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) Phase 3
Active, not recruiting NCT04595825 - CM-101 in PSC Patients -The SPRING Study Phase 2
Recruiting NCT03183570 - Detection of Integrin avb6 in IPF, PSC, and COVID19 Using PET/CT Early Phase 1
Completed NCT02943460 - Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis Phase 2
Completed NCT00951327 - Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP) N/A
Completed NCT04024813 - A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC Phase 2
Recruiting NCT05912387 - Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study Early Phase 1
Completed NCT02884557 - NKT Role in the Regulation of the Inflammatory Bowel Disease N/A
Recruiting NCT01398917 - Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis Phase 3