HTLV-I InfectionsPhase 4NCT03226119
MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study
A Phase 4 study testing MP Diagnostics HTLV Blot 2.4 in people with HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC at 3 sites in United States.
Trial summary
This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50). 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jan 2018to 31 Aug 2018
- Phase
- Phase 4
- 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
Who may be able to join
- All Specimens:
- Male or female
- Biorepository specimen de-identified of PHI
- Specimen meets HTLV Blot 2.4 labeling collection/handling criteria
- HTLV Positive Specimens:
- Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II
Show all 21Show fewer
- Neurological Disorders:
- Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:
- Acute Disseminated Encephalitis
- Amyotrophic Lateral Sclerosis (ALS)
- Autonomic Dysfunction
- Conus Medularis Syndrome
- Chronic Inflammatory Demyelinating Polyneuropathy
- Dermatomyositis
- HTLV associated myelopathy-tropical spastic paraparesis (HAM-TSP)
- Meningitis
- Mild Cognitive Impairment
- Multiple Sclerosis (MS)
- Polymyositis
- Spastic Paraparesis
- Sciatica
Who cannot join
- HTLV Infected:
- specimens with a known infection or history of HIV, HCV or HBV
- specimens not meeting specimen labeling collection / handling criteria
- Neurological Disorders
- specimens not meeting specimen labeling collection / handling criteria
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eastern Virginia Medical School (EVMS)
Norfolk, Virginia, 23507
LABS, Inc.
Philadelphia, Pennsylvania, 19123
Qualtex Laboratories
San Antonio, Texas, 78201
About this study
Official title: HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).
Read the detailed description
The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.
- 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 Infected (n=50) | Experimental | Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP) Receives: Diagnostic Test: MP Diagnostics HTLV Blot 2.4 |
| Neurological Disorders (n=100) | Experimental | Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica 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.
To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens
Measured: 3 months
To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens
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 posted21 Jul 2017
- Study start15 Jan 2018
- Primary completion10 Jul 2018
- Study completion31 Aug 2018
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 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
- Sara Dionne, PhD, Principal investigator, LABS, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226119
- Sponsor's protocol ID
- MP-EIA-HTLV-002B
- Status last verified
- Sep 2017
- First submitted
- 19 Jul 2017
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All clinical study data will be compiled and shared with investigators following database lock.
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 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
- ClinicalTrials.gov ID
- NCT03226119
- Acronym / sponsor ID
- MP-EIA-HTLV-002B
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- MP Biomedicals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- MP Biomedicals Asia Pacific Pte. Ltd.
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 21 Jul 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.
This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).
Detailed description
The HTLV Blot 2.4 Post-Market Clinical Study is an open-label, multi-center, single-blind clinical study of neurological disorders (n=100) and HTLV known-positive (KP) specimens (n=50). This study is being conducted to support additional labeling claims and to further assess the sensitivity and specificity of the HTLV Blot 2.4 in specimens with neurological disorders and HTLV known positive specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
| Arm | Type | Receives |
|---|---|---|
| HTLV Infected (n=50) | Experimental | Diagnostic Test: MP Diagnostics HTLV Blot 2.4Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP) |
| Neurological Disorders (n=100) | Experimental | Diagnostic Test: MP Diagnostics HTLV Blot 2.4Serum/plasma specimens with symptoms or any of the following neurological disorders: Acute Disseminated Encephalitis, Amyotrophic Lateral Sclerosis, Autonomic Dysfunction, Conus Medularis Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Dermatomyositis, HAM-TSP, Meningitis, Mild Cognitive Impairment, Multiple Sclerosis, Polymyositis, Spastic Paraparesis, Sciatica |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Male or female
- Biorepository specimen de-identified of PHI
- Specimen meets HTLV Blot 2.4 labeling collection/handling criteria
- Specimens with a known positive infection of HTLV I, HTLV II or HTLV I/II
- Specimens with a diagnosis or symptoms consistent with any of the following neurological disorders:
Key exclusion criteria (5 listed)
- specimens with a known infection or history of HIV, HCV or HBV
- specimens not meeting specimen labeling collection / handling criteria
- Neurological Disorders
- specimens not meeting specimen labeling collection / handling criteria
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 Infected (n=50), Neurological Disorders (n=100) |
Primary outcome
To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens
Time frame: 3 months
To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens
Time frame: 3 months
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 13 Sep 2018.
- 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. All clinical study data will be compiled and shared with investigators following database lock.
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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.
Sara Dionne, PhD principal investigator
LABS, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MP Diagnostics HTLV Blot 2.4 in people with HTLV-I Infections and HTLV-II Infections, run by MP Biomedicals, LLC 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 21 inclusion and 5 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 13 Sep 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03226119, 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 13 Sep 2018.