Clinical trials in TB
Optimization of the RTT method for the differentiation of patients/subjects with active or latent tuberculosis infection and non-infected patients/subjects
"A multi-marker solution running on widely available platforms"
This ongoing multicenter non-interventional study aims to improve our proprietary blood-based multi-marker solution, which can be run on widely available platforms, to deliver a significant improvement on TB infection detection over existing approaches. The study goal is to advance biomarker combinations which are able to differentiate between active TB disease and latent TB infection.
Development of improved diagnostics to distinguish between active tuberculosis and latent Mtb infection
"A feasibility study to target the goal of improved TB diagnostics"
This national multicenter non-interventional feasibility study including 240 blood samples has been carried out to improve the RT-qPCR-based diagnostics to distinguish between active and latent tuberculosis disease.
Investigation on the correlation of the degree of differentiation of M. tuberculosis-specific T lymphocytes with the status of a tuberculosis disease
"A feasibility study that aimed the differentiation of active and latent TB"
This national multicenter non-interventional feasibility study including 146 blood samples has been carried out to identify suitable tuberculosis-specific antigens that allow, based on Lophius' RT technology, the differentiation between latent and active tuberculosis.
Clinical trials in CMV
AlloProtectCMV study: Clinical validation of Lophius Biosciences’ T-Track® CMV in allo-HSCT recipients
“Identification of a possible prognostic marker for higher risk of recurrent CMV reactivation”
This multicenter observational study in a cohort of allogenic hematopoietic stem cell transplantation (allo-HSCT) recipients aimed to validate the suitability of Lophius’ T-Track® CMV assay to assess the functionality of CMV-reactive effector cells and to predict recurrent CMV reactivation in allo-HSCT patients.
CMV-CMI study: Cell-mediated immunity for prevention of CMV disease in SOT patients
“T-Track® CMV as a decision guidance for the duration of antiviral prophylaxis following SOT”
This ongoing interventional randomized controlled trial in high-risk solid-organ transplant (SOT) recipients aims to adapt the duration of antiviral prophylaxis according to the result of Lophius’ T-Track® CMV assay. The two main endpoints of the study are clinical outcome and health-economic benefit.
CMValue study: Clinical validation of Lophius Biosciences’ kit T-Track® CMV in kidney transplant recipients
“T-Track® CMV is a sensitive immune-monitoring tool in immunosuppressed renal transplant recipients”
This completed multicenter observational study aimed to validate the suitability of Lophius Biosciences’ T-Track® CMV to assess the functionality of CMV-specific cell-mediated immunity in immunocompromised patients following kidney transplantation.
- Banas B et al. (2018). Clinical validation of a novel enzyme‐linked immunosorbent spot assay‐based in vitro diagnostic assay to monitor cytomegalovirus‐specific cell‐mediated immunity in kidney transplant recipients: a multicenter, longitudinal, prospective, observational study. Transpl. Int. 31(4):436-450.
Validation of T-Track® CMV in hemodialysis patients
“T-Track® CMV is a reliable and sensitive assay for the detection of CMV-specific cell-mediated immunity in patients eligible for kidney transplantation”
This multicenter observational study aimed to determine Lophius Biosciences’ T-Track® CMV sensitivity in hemodialysis patients and compare it to that of competitor products. T-Track® CMV showed a 90% sensitivity in CMV-seropositive patients, compared to 73% for QuantiFERON®-CMV and 77% for six selected iTAg™ MHC Tetramers.
- Banas B. et al. (2017). Validation of T-Track® CMV to assess the functionality of cytomegalovirus-reactive cell-mediated immunity in hemodialysis patients. BMC Immunol. 18(1):15.
T-Track® CMV assay development and performance characteristics in healthy individuals
“An optimized IFN-y ELISpot assay for the sensitive and standardized monitoring of CMV”
In this study, performance characteristics of T-Track® CMV IFN-γ ELISpot assay for the monitoring of CMV-specific CMI were validated in healthy individuals. Results show that stimulation with T-activated® proteins results in improved assay sensitvity and a HLA antigen-independent application. T-Track® CMV demonstrates robust performance in terms of assay precision (CV≤22%) and linearity.
- Barabas S et al. (2017). An optimized IFN-γ ELISpot assay for the sensitive and standardized monitoring of CMV protein-reactive effector cells of cell-mediated immunity. BMC Immunol. 18(1):14.
Validation of T-Track® CMV during pregnancy
“T-Track® CMV can detect impaired CMV-specific cell-mediated immunity during and after pregnancy”
Reuschel E et al. (2017), Functional impairment of CMV-reactive cellular immunity during pregnancy. J. Med. Virol. 89:324–331. doi:10.1002/jmv.24639
Clinical trials coordination and cooperations
Lophius Biosciences is always interested in new cooperations regarding our clinical trials.
You're welcome to contact us if you are interested in a cooperation or if you have questions about our clinical trial program.