NCT05618275

Brief Summary

The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood. The virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. Cellular immunosuppression favors BKV replication. It is responsible for pathologies of the renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or ureteral stenosis. To date, there is no specific antiviral treatment against BKV. The management of patients is essentially symptomatic and requires a multidisciplinary approach. It is therefore necessary to identify early prognostic markers for the occurrence of CH and to develop new therapeutic strategies.

Trial Health

43
At Risk

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 Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

November 8, 2022

Last Update Submit

November 8, 2022

Conditions

BK Virus Infection

Keywords

BK virus infectionNeutralizing antibodiesHematopoietic stem cellPolyomaviridae

Outcome Measures

Primary Outcomes (1)

  • Retrospective study of the role of anti-BKV neutralizing antibodies in HSCT patients in the pediatric oncology-hematology department of the HUS

    Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined

Eligibility Criteria

Age1 Year - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019

You may qualify if:

  • Adult patient aged 18 to 19 years
  • Minor patient (from birth to 17 years old)
  • HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019

You may not qualify if:

  • Opposition of the patient (or parental authority holders) to participate in the study
  • Patient deprived of liberty or under court protection
  • Patient under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Samira FAFI-KREMER, PharmD

CONTACT

33 3 69 55 14 38samira.fafi-kremer@chru-strasbourg.fr

Study Design

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

Study Record Dates

First Submitted

November 8, 2022

First Posted

November 16, 2022

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

FR(1)