Screening for the Presence of HIV-1, RNA and HBV DNA in Blood DonationsNCT00552214
Evaluation of HIV-1, HCV and HBV Blood Screening Tests With Human Blood Donor Specimens
A study testing Blood test in people with Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations, run by Novartis at 1 site in Taiwan.
Trial summary
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission. Read more about this study
- Who is it for?
- Ages 17 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations
- What is being tested?
- Blood test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,290 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Aug 2007to 1 Jul 2008
- 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 17 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility
Who cannot join
- A positive (reactive) HIV and/or HCV and/or HBV test
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Blood Center Taiwan Blood Service Foundation (TBSF)
Taipei, 100
About this study
Official title: Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.
- Being tested
- Blood test
- Keywords
- Nucleic acid test, HIV-1, hepatitis, HBV, HCV, TMA, HIV Seronegativity
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDevice
Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
| Study group | Role | What they receive |
|---|---|---|
| Human Blood Donor Plasma Specimens | Other | Not described Receives: Device: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Measured: 01 August 2007 to 31 December 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study start8 Aug 2007
- Primary completion1 Jul 2008
- Study completion1 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening for the Presence of HIV-1, RNA and HBV DNA in Blood DonationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Grifols Biologicals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552214
- Sponsor's protocol ID
- ULT-001-TW1-Amendment 1.1
- Status last verified
- Feb 2021
- First submitted
- 30 Oct 2007
- Last updated
- 21 Feb 2021
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
- ClinicalTrials.gov ID
- NCT00552214
- Acronym / sponsor ID
- ULT-001-TW1-Amendment 1.1
- Keywords
- Nucleic acid test, HIV-1, hepatitis, HBV, HCV, TMA, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,290 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2007
- Primary completion
- 1 Jul 2008 (actual)
- Study completion
- 1 Jul 2008 (actual)
- First posted
- 1 Nov 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.
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Blood Donor Plasma Specimens | Other | Device: Blood test |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility
Key exclusion criteria (1 listed)
- A positive (reactive) HIV and/or HCV and/or HBV test
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 |
|---|---|---|
| Blood testScreening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens | Device | Human Blood Donor Plasma Specimens |
Primary outcome
Sensitivity and Specificity
Time frame: 01 August 2007 to 31 December 2007
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 21 Feb 2021.
- Novartis results databaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Study Director study director
Grifols Biologicals, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood test in people with Screening for the Presence of HIV-1, RNA and HBV DNA in Blood Donations, run by Novartis at 1 site in Taiwan.
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 1 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 21 Feb 2021. 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 Taiwan. 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?
Sensitivity and Specificity (time frame: 01 August 2007 to 31 December 2007). 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 21 Feb 2021.