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A Trial of BTT1023 in Patients With Primary Sclerosing Cholangitis

NCT02239211 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-05-03

No results posted yet for this study

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).

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

BTT1023

IV (in the vein) Investigational Medicinal Product (IMP)

Sponsors & Collaborators

  • Biotie Therapies Corp.

    collaborator INDUSTRY

  • University Hospital Birmingham

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Philip Newsome, MD · University of Birmingham

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-08
Primary Completion
2018-10-23
Completion
2018-10-23

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239211 on ClinicalTrials.gov