CMVNCT03502161
Clinical Evaluation of the QuantiFERON CMV Assay
An observational study of CMV, run by QIAGEN Gaithersburg, Inc at 1 site in United States.
Trial summary
Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV
- What is being tested?
- QuantiFERON CMV Assay
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.
Who may be able to join
- Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
- Scheduled to receive between 3 to 6 months of antiviral prophylaxis
- Provide Informed Consent
Who cannot join
- Subjects less than 18 years old
- Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
- Unable to provide Informed Consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.
- Conditions
- CMV
- Being tested
- QuantiFERON CMV Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantiFERON CMV AssayDevice
Assay to measure cell-mediated immune function using QuantiFERON CMV assay.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Those receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis. Receives: Device: QuantiFERON CMV Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.
Measurement of QF-CMV result
Measured: At time of prophylaxis termination, +1 month from termination, +2 months from termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start15 Nov 2018
- Primary completion15 May 2020
- Study completion30 Jun 2020
Why it stopped: Business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502161
- Sponsor's protocol ID
- C16-CMV-001
- Status last verified
- Sep 2020
- First submitted
- 4 Apr 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.
Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20.
PubMed 11229841
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the QuantiFERON CMV Assay
- ClinicalTrials.gov ID
- NCT03502161
- Acronym / sponsor ID
- C16-CMV-001
- Conditions
- CMV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Device: QuantiFERON CMV AssayThose receiving a SOT and coming off either 3 months or 6 months of antiviral prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CMV D+/R- SOT recipients older than 18 that are receiving 3-6 months of antiviral prophylaxis and can provide Informed Consent.
Key inclusion criteria (3 listed)
- Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
- Scheduled to receive between 3 to 6 months of antiviral prophylaxis
- Provide Informed Consent
Key exclusion criteria (3 listed)
- Subjects less than 18 years old
- Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
- Unable to provide Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuantiFERON CMV AssayAssay to measure cell-mediated immune function using QuantiFERON CMV assay. | Device | All subjects |
Primary outcome
Change in time to CMV Infection between sub-groups of QF-CMV assay classifications.
Time frame: At time of prophylaxis termination, +1 month from termination, +2 months from termination
Measurement of QF-CMV result
Results and safety
The study was stopped early (reason given: Business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- BackgroundTolkoff-Rubin N, Rubin R. The impact of cytomegalovirus infection on graft function and patient outcome. Graft 1999; 2:S101-3.
- Background: PubMed 11229841Singh N. Preemptive therapy versus universal prophylaxis with ganciclovir for cytomegalovirus in solid organ transplant recipients. Clin Infect Dis. 2001 Mar 1;32(5):742-51. doi: 10.1086/319225. Epub 2001 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV, run by QIAGEN Gaithersburg, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to CMV Infection between sub-groups of QF-CMV assay classifications. (time frame: At time of prophylaxis termination, +1 month from termination, +2 months from termination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.