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NCT05618275 Clinical Trial

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

BK Virus Infection Clinical Trial

— BKV-Allograf  

Official title:
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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05618275
Other study ID # 7635
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information
Verified date November 2022
Source University Hospital, Strasbourg, France
Contact Samira FAFI-KREMER, PharmD
Phone 33 3 69 55 14 38
Email samira.fafi-kremer@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 1 Year to 19 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Active, not recruiting NCT05026021 - Prediction of BKvirus Nephropathy Risk by the NEPHROVIR Method in Kidney Transplant Patients With BKvirus Viremia
Recruiting NCT05511779 - Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation Phase 2
Recruiting NCT05183490 - R-MVST Cells for Treatment of Viral Infections Phase 1
Active, not recruiting NCT00684372 - BK Viremia After Renal Transplantation N/A
Recruiting NCT06219616 - Prediction of BK Virus Reactivation in Kidney Transplant Recipient N/A
Not yet recruiting NCT05264259 - New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Completed NCT04605484 - Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia Phase 2
Terminated NCT05305040 - Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Terminated NCT04390113 - Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) Phase 3
Withdrawn NCT02313844 - Most Closely Human Leukocyte Antigen (HLA)-Matched BK Virus-specific T Lymphocytes (Viralym-B) Phase 1
Active, not recruiting NCT03532971 - Prospective Study of BK Virus Disease After Allogeneic Hematopoietic-cell Transplantation: Defining BK Disease's Natural History, Clinical Spectrum, Immunology, and Outcomes
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Recruiting NCT05101213 - Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients Phase 1
Completed NCT01789203 - Ciprofloxacin for Prevention of BK Infection Phase 4
Completed NCT04693637 - Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Recruiting NCT04542733 - The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient N/A
Recruiting NCT05042076 - BK With VST for Kidney Transplant Patients Phase 1
Completed NCT04294472 - A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients Phase 2