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.

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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 ongoing multicenter observational study in a cohort of allogenic hematopoietic stem cell transplantation (allo-HSCT) recipients aims 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.

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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.

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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.

 

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Transplant International Open Access


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.

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BMC Immunology Open Access


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.

BMC Immunology Open Acess


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

PubMed


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.     

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