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

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

• Registration Number: DRKS00010056
• Lead Sponsor: ophius Biosciences GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-09
• Results First Posted: 2017-03-07
• Study Completion: 2017-05-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 49

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

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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>

Secondary Outcome Measures

Name	Time	Method
not applicable