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NCT05264259 Clinical Trial

New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

BK Virus Infection Clinical Trial

— AcMBK  

Official title:
New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05264259
Other study ID # 8521
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 5, 2022
Est. completion date December 1, 2025

Study information
Verified date February 2022
Source University Hospital, Strasbourg, France
Contact Anne-Sophie U GEY
Phone +33 388116684
Email anne-sophie.gey@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date December 1, 2025
Est. primary completion date March 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - BK positive - adult - ok to participed to research Exclusion Criteria: - under guardianship - under curatorship - opposed to research - deprived of liberty

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Virologie - CHU 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 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) 5 years
See also
  Status Clinical Trial Phase
Withdrawn NCT02758288 - BK Virus Post-Kidney Transplant: New Practice Versus Traditional Approach
Completed NCT01624948 - Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients Phase 4
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
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
Recruiting NCT02479698 - Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus Phase 2
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 NCT05618275 - 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
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