HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
| Registry | NCT03226119 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; non randomized, parallel, masking: single, diagnostic |
| Enrollment | 150 (Actual) |
| Sponsor | MP Biomedicals, LLC (Industry); collaborators: MP Biomedicals Asia Pacific Pte. Ltd. |
| 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 |
| Interventions | MP Diagnostics HTLV Blot 2.4 (Diagnostic test) |
| Dates | start 2018-01-15, primary completion 2018-07-10, completion 2018-08-31, first posted 2017-07-21, last updated 2018-09-13 |
| Locations | 3 sites in United States |
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All trials for HTLV-I Infections All trials for HTLV-II Infections All trials of MP Diagnostics HTLV Blot 2.4
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| HTLV Infected (n=50) | Experimental | Diagnostic Test: MP Diagnostics HTLV Blot 2.4 | Serum/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 2.4 | 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 |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 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 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 Exclusion Criteria: 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
| Facility | City | Country | Status |
|---|---|---|---|
| LABS, Inc. | Philadelphia, Pennsylvania | United States | |
| Qualtex Laboratories | San Antonio, Texas | United States | |
| Eastern Virginia Medical School (EVMS) | Norfolk, Virginia | United States |