Research on the improvement of ease of use and product safety of T-Track® CMV kit

Research on the improvement of ease of use and product safety of T-Track® CMV kit - CMVextend, LB-D1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010056

Enrollment

270

Registered

2016-06-09

Start date

2015-03-31

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PMCF-study with CE marked in vitro diagnostic device to improve product safety and ease of use of T-Track® CMV kit.

Interventions

Group 1: For the research on the improvement of ease of use and product safety of T-Track® CMV about 870 blood samples of 100 CMV-seropositive healthy individuals and about 360 blood samples of 50 CMV

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: healthy individuals: - written informed consent, - male or female at least 18 years of age - 100 CMV-seropositive probands - 50 CMV-seronegative probands additional criteria for patients receiving a kidney graft: - patient has received a kidney graft - patient is CMV-seropositive additional criteria for patients receiving a bone-marrow transplant: - allogeneic hematopoietic stem cell transplantation at least 3 months before blood collection - patient is CMV-seropositive at the time of blood collection

Exclusion criteria

Exclusion criteria: healthy individuals: - acute infectious diseases - test person is known to be positive for HBV, HCV or HIV infection - any form of alcohol or substance abuse - hemodynamic instability - any form of psychiatric disorder - defect of innate / adaptive immune system additional criteria for patients receiving a kidney graft: - patients receiving ATG at time of blood withdrawal or within a period of 30 days prior to blood withdrawal - patient has significant uncontrolled concomitant infections or other unstable medical conditions that, in the opinion of the investigator may indicate that the patient is ineligible for blood withdrawal additional criteria for patients receiving a bone marrow transplant: - patients receiving haploidentical allogeneic hematopoietic stem cell graft - patients receiving Alemtuzumab at time of blood withdrawal or within a period of 30 days prior to blood withdrawal

Design outcomes

Primary

Measure	Time frame
examination of influence of deviating or extension of storage conditions of blood samples on test result, development of freezing and thawing protocols and analysis of various stimulation periods	—

Countries

Germany

Contacts

Public ContactTraudel Schmidt

Lophius Biosciences GmbH

Traudel.Schmidt@Lophius.com+49 (0)941 6309197-39

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026