BK Virus InfectionBKV-AllografNCT05618275
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
An observational study of BK Virus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 19 years
- Conditions the study is for
- BK Virus Infection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 19 years
- All sexes
- Child, Adult
Study population: HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Strasbourg, 67091
Samira FAFI-KREMER, PharmD, PhD, 33 3 69 55 14 38, samira.fafi-kremer@chru-strasbourg.fr
Samira FAFI-KREMER, PharmD, PhD
About this study
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)
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.
- Conditions
- BK Virus Infection
- Keywords
- BK virus infection, Neutralizing antibodies, Hematopoietic stem cell, Polyomaviridae
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective study of the role of anti-BKV neutralizing antibodies in HSCT patients in the pediatric oncology-hematology department of the HUS
Measured: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jan 2020
- Primary completionDec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK Virus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618275
- Sponsor's protocol ID
- 7635
- Acronym
- BKV-Allograf
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05618275
- Acronym / sponsor ID
- BKV-Allograf / 7635
- Conditions
- BK Virus Infection
- Keywords
- BK virus infection, Neutralizing antibodies, Hematopoietic stem cell, Polyomaviridae
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Retrospective study of the role of anti-BKV neutralizing antibodies in HSCT patients in the pediatric oncology-hematology department of the HUS
Time frame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
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ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
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Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of BK Virus Infection, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samira FAFI-KREMER, PharmD (33 3 69 55 14 38, samira.fafi-kremer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retrospective study of the role of anti-BKV neutralizing antibodies in HSCT patients in the pediatric oncology-hematology department of the HUS (time frame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.