Trial Outcomes & Findings for Evaluation of the Artus® CMV PCR Test (NCT NCT01034709)
NCT ID: NCT01034709
Last Updated: 2014-08-20
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
111 participants
Primary outcome timeframe
3 months
Results posted on
2014-08-20
Participant Flow
Participant milestones
| Measure |
Symptomatic
Subjects with a confirmed CMV viremia by the site's CMV-LDT
|
Asymptomatic
Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
58
|
|
Overall Study
COMPLETED
|
44
|
42
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
| Measure |
Symptomatic
Subjects with a confirmed CMV viremia by the site's CMV-LDT
|
Asymptomatic
Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
16
|
Baseline Characteristics
Evaluation of the Artus® CMV PCR Test
Baseline characteristics by cohort
| Measure |
Symptomatic
n=44 Participants
Subjects with a confirmed CMV viremia by the site's CMV-LDT
|
Asymptomatic
Subjects who are serologically negative for CMV IgG
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
—
|
49 years
n=5 Participants
|
|
Gender
Female
|
19 participants
n=5 Participants
|
—
|
19 participants
n=5 Participants
|
|
Gender
Male
|
25 participants
n=5 Participants
|
—
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
—
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American/ Not Hispanic or Latino
|
14 participants
n=5 Participants
|
—
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/Hispanic or Latino
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Hispanic or Latino
|
8 participants
n=5 Participants
|
—
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Not Hispanic or Latino
|
9 participants
n=5 Participants
|
—
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
4 participants
n=5 Participants
|
—
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
—
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Symptomatic
n=44 Participants
Subjects with a confirmed CMV viremia by the site's CMV-LDT
|
Asymptomatic
n=42 Participants
Subjects who are serologically negative for CMV IgG
|
|---|---|---|
|
a) CMV Viral Load
LOQ IU/ml
|
86.36 percentage of agreement
|
NA percentage of agreement
No participants with detectable level in this group
|
|
a) CMV Viral Load
500 IU/ml
|
95.45 percentage of agreement
|
NA percentage of agreement
No participants with detectable level in this group
|
|
a) CMV Viral Load
1000 IU/ml
|
90.91 percentage of agreement
|
NA percentage of agreement
No participants with detectable level in this group
|
|
a) CMV Viral Load
Not Detected
|
100 percentage of agreement
|
97.6 percentage of agreement
|
Adverse Events
Symptomatic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Asymptomatic
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kevin Modarress, PhD Senior Manager Regulatory Affairs Operations NA, Regulatory Affairs
QIAGEN
Phone: 301-944-7103
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place