Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS

Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the University Hospital of Strasbourg (HUS)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05618275

Acronym

BKV-Allograf

Enrollment

100

Registered

2022-11-16

Start date

2020-01-01

Completion date

2022-12-31

Last updated

2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BK Virus Infection

Keywords

BK virus infection, Neutralizing antibodies, Hematopoietic stem cell, Polyomaviridae

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 19 Years

Inclusion criteria

* 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

Exclusion criteria

* Opposition of the patient (or parental authority holders) to participate in the study * Biological resources from a patient who does not meet all inclusion criteria * Patient deprived of liberty or under court protection * Patient under guardianship or curatorship

Design outcomes

Primary

Measure	Time frame
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

Countries

France

Contacts

Primary ContactSamira FAFI-KREMER, PharmD

samira.fafi-kremer@chru-strasbourg.fr33 3 69 55 14 38

Outcome results