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AcMBK: New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05264259
Collaborator
(none)
100
Enrollment
1
Location
44.9
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

BK virus (BKV) infection has a major negative impact on transplant recipients. No BKV-specific antiviral therapy is available, so there is an urgent need to develop new anti-BKV preventive and therapeutic strategies.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
    Anticipated Study Start Date :
    Mar 5, 2022
    Anticipated Primary Completion Date :
    Mar 5, 2022
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes [5 years]

      The neutralization titer will be defined as the dilution of the sample that produced 50% inhibition of pseudovirion infectivity (IC50)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • BK positive

    • adult

    • ok to participed to research

    Exclusion Criteria:

    • under guardianship

    • under curatorship

    • opposed to research

    • deprived of liberty

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Virologie - CHU Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Samira FAFI-KREMER, University Hospital, Strasbourg, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05264259
    Other Study ID Numbers:
    • 8521
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Virus Diseases

    Study Results

    No Results Posted as of Mar 3, 2022