NCT05264259

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2022

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

Same day

First QC Date

February 7, 2022

Last Update Submit

August 4, 2025

Conditions

BK Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Ability of the isolated monoclonal antibodies to neutralize all 3 BKV genotypes

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

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Adult patient with a posititive serology BK confirmed

You may qualify if:

  • BK positive
  • adult
  • ok to participed to research

You may not qualify if:

  • under guardianship
  • under curatorship
  • opposed to research
  • deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Virologie - CHU Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Officials

  • Samira FAFI-KREMER

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie U GEY

CONTACT

+33 388116684anne-sophie.gey@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

March 3, 2022

Study Start

September 5, 2022

Primary Completion

September 5, 2022

Study Completion

December 1, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations

FR(1)