CClinicalTrials.gg
RecruitingNCT05264259AcMBKUpdated Aug 8, 2025

New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

An observational study in BK Virus Infection, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • BK Virus Infection
03

In context

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

- Adult patient with a posititive serology BK confirmed

Inclusion criteria

  • BK positive
  • adult
  • ok to participed to research

Exclusion criteria

Exclusion Criteria:

  • under guardianship
  • under curatorship
  • opposed to research
  • deprived of liberty
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

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)

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05264259
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Mar 3, 2022
Start date
Sep 5, 2022
Primary completion
Sep 5, 2022
Completion
Dec 1, 2025 (estimated)
Last update
Aug 8, 2025

Study contacts

Anne-Sophie U GEY
Contact
anne-sophie.gey@chru-strasbourg.fr
+33 388116684
Samira FAFI-KREMER
principal investigator · University Hospital, Strasbourg, France

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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