Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05064462
Other study ID # APHP201167
Secondary ID 2020-A03456-33
Status Active, not recruiting
Phase
First received
Last updated
Start date March 3, 2022
Est. completion date March 3, 2024

Study information

Verified date February 2024
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation. The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.


Description:

TTV (Torque Teno Virus) is a ubiquitous virus that is not associated with any disease. A correlation exists between the level of TTV replication and the subject's immunocompetence: weak or non-existent in immunocompetents, very high in immunocompromised patients. In heart transplant patients, pharmacological dosing of immunosuppressants prevents their toxic manifestations but is not correlated with individual immune competence. Only clinical manifestations of overdose (infections) or under dosage (rejections) currently allow optimization of immunosuppressants. A predictive biomarker of these clinical manifestations upstream of their appearance would revolutionize the management of these patients. The TTV fulfills the conditions to be an ideal biomarker: classic blood sampling, possible follow-up in all patients, low cost, carrying out the analysis on already existing molecular biology platforms, reproducibility of inter- and intra-laboratory results, defined thresholds for the reliable interpretation of the results. We believe that this marker will provide the clinician with a useful tool for the management of immunosuppressants and the patient with personalized medicine which will allow their management to be individualized. If this study confirms the expected results, then it will allow, secondly, the setting up of interventional studies to validate the TTV viral load as a biomarker, and a tool for piloting immunosuppressive treatment. The TTV viral load of heart transplant patients will be follow during the first year after transplantation. A tube of blood will be taken during the transplant and then once or twice a month. Samples will be taken at the same time as those taken as part of standard care. The TTV viral load will be measured at the end of the study. The occurrence of events of interest (infections and rejections) will be collected at each corresponding visit.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date March 3, 2024
Est. primary completion date March 3, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age =18 years - Heart transplant only - First transplant - Patient not having objected to carrying out the research - Affiliated to a French Health Insurance system. Exclusion Criteria: - Patient transplanted from more than one solid organ - Patient who has already been transplanted before - Patient under guardianship or curatorship - Patient under legal protection - Pregnant or breastfeeding woman

Study Design


Intervention

Other:
Collection of EDTA blood sample (5 to 7 ml)
For all the patients included in the study, the samples to measure the viral load will be taken during the transplantation, then at each of the consultations planned as part of the usual care during the first year post-transplant (at minimum once and maximum twice a month). These samples will be taken at the same time as those taken as part of standard care.

Locations

Country Name City State
France Hôpital européen Georges Pompidou Paris
France CHU de Rennes Rennes
France CHU Strasbourg Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris BioMérieux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite outcome : Infections or Rejections The primary endpoint is a composite endpoint defined as time to infections (first and recurrences) or rejections (first and recurrences) within the 12 months post-transplant:
Infections are defined as viral Infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization
Rejections are defined as acute type 2R or 3R cell rejections according to the ISHLT classification
12 months
Secondary TTV viral load Monthly mean of TTV viral concentration load measured by quantitative PCR within 3 months 3 months
Secondary TTV viral load Monthly mean of TTV viral concentration measured by quantitative PCR within 12 months 12 months
Secondary Infections Time to viral infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization during the 12 months post-transplant. 12 months
Secondary Rejections Time to rejections within the 12 months post-transplant defined as acute type 2R or 3R cell rejections according to the ISHLT classification. 12 months
Secondary Immunosuppressant level Immunosuppressant pharmacological dosing 3 months
Secondary Immunosuppressant level Immunosuppressant pharmacological dosing 12 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03911388 - HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors Phase 1
Recruiting NCT06059027 - Microbes and Respiratory Illnesses
Completed NCT03463694 - Edinburgh and Lothian Virus Intervention Study in Kids N/A
Recruiting NCT04393415 - Using PRP and Cord Blood in Treatment of Covid -19 N/A
Not yet recruiting NCT05387226 - Intravenous Injection of Oncolytic Virus Injection (RT-01) in Patients With Relapsed or Refractory T-cell Lymphoma Phase 1
Recruiting NCT04336020 - The DETECT(Digital Engagement & Tracking for Early Control, & Treatment) Study
Recruiting NCT05727709 - Dynamic Changes of Torquetenovirus (TTV) Load in Chinese Renal Transplant Recipients
Recruiting NCT04382131 - Hypertonic Saline Nasal Irrigation and Gargling in Suspected or Confirmed COVID-19 (ELVIS COVID-19) N/A
Completed NCT02743663 - The Development of Novel Clinical Tests to Diagnose and Monitor Asthma in Preschool Children
Not yet recruiting NCT06396624 - Effects of Photobiomodulation on the Innate Immune System of Neonates and Infants With Bronchiolitis N/A
Not yet recruiting NCT06432855 - Genetic Determinants of the Antiviral Immune Response in Oceanian Populations N/A
Not yet recruiting NCT05868551 - Onchocerciasis-Associated Epilepsy, an Explorative Case-control Study
Completed NCT01136395 - Impact of Rituximab (RTx) Induction and Living Donation on Immunoregulation and Virus Control in Renal Transplantation Phase 2
Completed NCT01159561 - Western Equine Encephalitis Vaccine, Inactivated Phase 1
Completed NCT04636294 - Borderline COVID-19 PCR Test Result
Recruiting NCT04449978 - TARGet Kids! COVID-19 Study of Children and Families
Recruiting NCT06135844 - Hand Sanitizer Use for Herpes Simplex Virus-1 Early Phase 1
Recruiting NCT04348864 - COVID-19 Diagnostic Self-testing Using Virtual Point-of-care N/A