Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of the Artus® CMV PCR Test (CMV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01034709
Recruitment Status : Completed
First Posted : December 17, 2009
Results First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
QIAGEN Gaithersburg, Inc

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Cytomegalovirus Infections
Enrollment 111
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description Subjects with a confirmed CMV viremia by the site's CMV-LDT Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
Period Title: Overall Study
Started 53 58
Completed 44 42
Not Completed 9 16
Reason Not Completed
Protocol Violation             9             16
Arm/Group Title Symptomatic Asymptomatic Total
Hide Arm/Group Description Subjects with a confirmed CMV viremia by the site's CMV-LDT Subjects who are serologically negative for CMV IgG Total of all reporting groups
Overall Number of Baseline Participants 44 0 44
Hide Baseline Analysis Population Description
Age, gender, and race/ethnicity data was not collected for the Asymptomatic arm of this study.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants 0 participants 44 participants
49
(22 to 72)
49
(22 to 72)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 0 participants 44 participants
Female 19 19
Male 25 25
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants 0 participants 44 participants
Asian 6 6
Black or African American/ Not Hispanic or Latino 14 14
Black/Hispanic or Latino 1 1
White/Hispanic or Latino 8 8
White/Not Hispanic or Latino 9 9
Other 1 1
Native Hawaiian/Other Pacific Islander 1 1
Hispanic/Latino 4 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 0 participants 44 participants
44 44
1.Primary Outcome
Title a) CMV Viral Load
Hide Description The CMV viral load was measured by both the artus CMV RG PCR test and the COBAS® AmpliPrep/COBAS® TaqMan® CMV Test at the investigational sites and then the percent agreement between the two tests was determined.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description:
Subjects with a confirmed CMV viremia by the site's CMV-LDT
Subjects who are serologically negative for CMV IgG
Overall Number of Participants Analyzed 44 42
Measure Type: Number
Unit of Measure: percentage of agreement
Not Detected 100 97.6
LOQ IU/ml 86.36 NA [1] 
500 IU/ml 95.45 NA [1] 
1000 IU/ml 90.91 NA [1] 
[1]
No participants with detectable level in this group
Time Frame At time of blood collection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symptomatic Asymptomatic
Hide Arm/Group Description Subjects with a confirmed CMV viremia by the site's CMV-LDT Subjects who are serologically negative for CMV IgG
All-Cause Mortality
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/42 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symptomatic Asymptomatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/42 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Kevin Modarress, PhD Senior Manager Regulatory Affairs Operations NA, Regulatory Affairs
Organization: QIAGEN
Phone: 301-944-7103
Publications:
Responsible Party: QIAGEN Gaithersburg, Inc
ClinicalTrials.gov Identifier: NCT01034709     History of Changes
Other Study ID Numbers: C09-CMV-001
First Submitted: December 15, 2009
First Posted: December 17, 2009
Results First Submitted: July 8, 2014
Results First Posted: August 20, 2014
Last Update Posted: August 20, 2014