HTLV-I InfectionsNCT03146013
Dual Algorithm Post Market Clinical Study
An observational study of HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1
- What is being tested?
- MP Diagnostics HTLV Blot 2.4
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 May 2017
- 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: All populations are from whole blood donors.
Who may be able to join
- Male or female
- Completion of a health history evaluation for routine donor screening
- Provided a routine blood donation
- Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay
Who cannot join
- Unwilling or unable to provide informed consent to blood donation
- Inadequate sample volume for testing
- Unable to provide samples that meet the suitability requirements for testing
Trial locations and contacts
1 site in 1 country.
United States1 site
American Red Cross - National Testing Laboratory
Charlotte, North Carolina, 28273
About this study
Official title: Evaluation of the MP Diagnostics HTLV Blot 2.4
The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).
Read the detailed description
This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.
- Conditions
- HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2, HTLV I Associated T Cell Leukemia Lymphoma, HTLV I Associated Myelopathies
- Being tested
- MP Diagnostics HTLV Blot 2.4
- Keywords
- HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II
- Medical subject headings
- HTLV-I Infections, HTLV-II Infections, Leukemia-Lymphoma, Adult T-Cell, Paraparesis, Tropical Spastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP Diagnostics HTLV Blot 2.4Diagnostic test
Also called HTLV I/II Western Blot Assay
HTLV I/II Confirmation and Differentiation
| Study group | Role | What they receive |
|---|---|---|
| HTLV Repeat Reactive (RR) / Non Reactive (NR) | Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay Receives: Diagnostic Test: MP Diagnostics HTLV Blot 2.4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the HTLV dual algorithm testing in blood donor facilities
HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Mar 2017
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HTLV-I InfectionsStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- MP Biomedicals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MP Biomedicals Asia Pacific Pte. Ltd.
- Responsible party
- Sponsor
- Investigators
- Susan Stramer, Ph.D, Principal investigator, American National Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146013
- Sponsor's protocol ID
- MP EIA-HTLV-001B Amendment 6.0
- Status last verified
- Jun 2017
- First submitted
- 5 May 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual patient data (IPD) was deidentified prior to sharing.
Publications
Miller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11.
PubMed 26589659
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the MP Diagnostics HTLV Blot 2.4
- ClinicalTrials.gov ID
- NCT03146013
- Acronym / sponsor ID
- MP EIA-HTLV-001B Amendment 6.0
- Conditions
- HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1, Human T-lymphotropic Virus 2, HTLV I Associated T Cell Leukemia Lymphoma, HTLV I Associated Myelopathies
- Keywords
- HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- MP Biomedicals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- MP Biomedicals Asia Pacific Pte. Ltd.
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 9 May 2017 (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.
The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).
Detailed description
This is a prospective study designed to assess the safety and effectiveness of a dual algorithm testing for HTLV I/II in blood donors. The study hypothesis is that blood donors testing repeat reactive (RR) on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed screening assay will be confirmed as indeterminate or negative on the MP Diagnostics HTLV Blot 2.4.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HTLV Repeat Reactive (RR) / Non Reactive (NR) | – | Diagnostic Test: MP Diagnostics HTLV Blot 2.4Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All populations are from whole blood donors.
Key inclusion criteria (4 listed)
- Male or female
- Completion of a health history evaluation for routine donor screening
- Provided a routine blood donation
- Tests repeat reactive by the Abbott PRISM HTLV assay and non-reactive on the AVIOQ Elisa HTLV assay
Key exclusion criteria (3 listed)
- Unwilling or unable to provide informed consent to blood donation
- Inadequate sample volume for testing
- Unable to provide samples that meet the suitability requirements for testing
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 |
|---|---|---|
| MP Diagnostics HTLV Blot 2.4Also: HTLV I/II Western Blot AssayHTLV I/II Confirmation and Differentiation | Diagnostic test | HTLV Repeat Reactive (RR) / Non Reactive (NR) |
Primary outcome
Assess the HTLV dual algorithm testing in blood donor facilities
Time frame: 3 months
HTLV I/II confirmation of specimens testing RR on the first FDA licensed HTLV screening assay and non-reactive (NR) on a second FDA licensed HTLV screening assay.
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 12 Jun 2017.
- Background: PubMed 26589659Miller L. Profile of the MP Diagnostics HTLV Blot 2.4 test: a supplemental assay for the confirmation and differentiation of antibodies to HTLV-1 and HTLV-2. Expert Rev Mol Diagn. 2016;16(2):135-45. doi: 10.1586/14737159.2016.1123622. Epub 2016 Jan 11.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) was deidentified prior to sharing.
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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.
Susan Stramer, Ph.D principal investigator
American National Red Cross
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 HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC 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 4 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: finished, as of the sponsor's last update on 12 Jun 2017. 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 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?
Assess the HTLV dual algorithm testing in blood donor facilities (time frame: 3 months). 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 NCT03146013, which also lists 1 linked publication.
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 12 Jun 2017.