A monoclonal antibody approach to treat BK virus infection.
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
This observational project will collect data to see if monoclonal antibody–based approaches could help adults with BK virus infection after transplantation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT05264259 on ClinicalTrials.gov |
What this trial studies
Researchers at the University Hospital Strasbourg will enroll BK virus–positive adults and follow their clinical course and laboratory markers over time. The protocol is observational and will collect virological data, clinical outcomes, and immune-related measurements to identify antibody targets and biomarkers. Collected data and samples may be used to support the development of monoclonal antibody treatments and to select candidates for future interventional trials. No experimental therapy is administered as part of this protocol.
Who should consider this trial
Good fit: Adults who are BK virus–positive and able to give informed consent, typically transplant recipients, are the intended participants.
Not a fit: People who are minors, under guardianship or curatorship, legally deprived of liberty, or who decline participation are excluded and would not directly benefit.
Why it matters
Potential benefit: If successful, this work could identify monoclonal antibody strategies that reduce BK virus complications and improve transplant outcomes.
How similar studies have performed: While monoclonal antibodies have been effective for other viral infections, their use specifically against BK virus is largely novel with limited clinical evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BK positive * adult * ok to participed to research Exclusion Criteria: * under guardianship * under curatorship * opposed to research * deprived of liberty
Where this trial is running
Strasbourg
- Service de Virologie - CHU Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Principal investigator: Samira FAFI-KREMER — University Hospital, Strasbourg, France
- Study coordinator: Anne-Sophie U GEY
- Email: anne-sophie.gey@chru-strasbourg.fr
- Phone: +33 388116684
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.