Journal
BMJ OPEN
Volume 7, Issue 6, Pages -Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2016-015081
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Funding
- NIHR Efficacy and Mechanism Evaluation (EME) Programme [12/165/31]
- National Institute for Health Research (NIHR) Birmingham Liver Biomedical Research Unit (BRU)
- Cancer Research UK [15958] Funding Source: researchfish
- Medical Research Council [MC_PC_14123, G0300101, G0700301, MR/M009157/1, G0300102, G0802577, G0400496] Funding Source: researchfish
- National Institute for Health Research [NF-SI-0512-10080, NF-SI-0616-10012, 12/165/31] Funding Source: researchfish
- MRC [G0400496, G0300102, G0802577, MR/M009157/1, G0700301, MC_PC_14123, G0300101] Funding Source: UKRI
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Introduction Primary sclerosing cholangitis (PSC) is a progressive inflammatory liver disease characterised by relentless liver fibrosis and a high unmet need for new therapies. Preventing fibrosis represents an important area of interest in the development of vital new drugs. Vascular adhesion protein-1 (VAP-1) drives inflammation in liver disease, and provision of an antibody against VAP-1 blunts fibrosis in murine models of liver injury. Methods and analysis BUTEO is a single-arm, two-stage, open-label, multi-centre, phase II clinical trial. Up to 59 patients will receive treatment with anti-VAP monoclonal antibody, BTT1023, over a 78-day treatment period. Adults with PSC and a serum alkaline phosphatase (ALP) of at least 1.5 times the upper limit of normal will be included. Our primary outcome measure is a reduction in ALP by >25% from baseline to Day 99. Secondary outcome measures include safety and tolerability, changes pre therapy/post therapy in circulating serum VAP-1 as well as imaging findings. The first patient participant was recruited on 08 September 2015. Ethics and dissemination This protocol has been approved by the Research Ethics Committee (REC, reference 14/EM/1272). The first REC approval date was 06 January 2015 with three subsequent approved amendments. This article refers to protocol V3.0, dated 16 March 2016. Results will be disseminated via peer-reviewed publication and presentation at international conferences.
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