Healthy VolunteerNCT00520273
A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA
A study testing cobas s 201 TaqScreen MPX Test in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites in United States.
Trial summary
This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- cobas s 201 TaqScreen MPX Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,000 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Oct 2007
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18-65 years of age
- Fulfil criteria for plasma donation
Who cannot join
- Do not fulfil criteria for plasma donation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Boca Raton, Florida, FL 33487
Study site
Memphis, Tennessee, TN 38134
Study site
Raleigh, North Carolina, 27619
About this study
This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.
- Conditions
- Healthy Volunteer
- Being tested
- cobas s 201 TaqScreen MPX Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobas s 201 TaqScreen MPX TestDevice
Donors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: cobas s 201 TaqScreen MPX Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rainer Ziermann, Study director, Roche Molecular Systems, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520273
- Sponsor's protocol ID
- RD000487
- Other IDs
- CAT-MPX-143
- Status last verified
- Jun 2010
- First submitted
- 22 Aug 2007
- Last updated
- 2 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA
- ClinicalTrials.gov ID
- NCT00520273
- Acronym / sponsor ID
- RD000487
- Conditions
- Healthy Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Aug 2007 (estimated)
- 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.
This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: cobas s 201 TaqScreen MPX Test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults 18-65 years of age
- Fulfil criteria for plasma donation
Key exclusion criteria (1 listed)
- Do not fulfil criteria for plasma donation
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 |
|---|---|---|
| cobas s 201 TaqScreen MPX TestDonors testing reactive for one or more of the viral markers will be advised to seek further advice/treatment from their physician. | Device | A |
Primary outcome
Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA
Time frame: Study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2016.
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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.
Rainer Ziermann study director
Roche Molecular Systems, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cobas s 201 TaqScreen MPX Test in people with Healthy Volunteer, run by Hoffmann-La Roche at 3 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Source plasma donors were screened for the presence of HIV-1 RNA, HBV DNA, and/or HCV RNA (time frame: Study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2016.