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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Sponsor
MP Biomedicals, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03226119
Collaborator
MP Biomedicals Asia Pacific Pte. Ltd. (Other)
150
Enrollment
3
Locations
2
Arms
7.5
Actual Duration (Months)
50
Patients Per Site
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: MP Diagnostics HTLV Blot 2.4
 Phase 4

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

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive SpecimensCohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens
Masking:
Single (Investigator)
Masking Description:
Clinical Sites and the Reference Core-Lab will be masked of specimen disease state
Primary Purpose:
Diagnostic
Official Title:
HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens
Actual Study Start Date :
Jan 15, 2018
Actual Primary Completion Date :
Jul 10, 2018
Actual Study Completion Date :
Aug 31, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: HTLV Infected (n=50)

Serum/plasma specimens which are HTLV I, HTLV II or HTLV I/II known positive (KP)

Diagnostic Test: MP Diagnostics HTLV Blot 2.4
HTLV I/II Confirmation and Differentiation
Other Names:
  • HTLV I/II Western Blot Assay

    		•
    Experimental: Neurological Disorders (n=100)

    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

    Diagnostic Test: MP Diagnostics HTLV Blot 2.4
    HTLV I/II Confirmation and Differentiation
    Other Names:
  • HTLV I/II Western Blot Assay

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens [3 months]

    2. To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LABS, Inc. Philadelphia Pennsylvania United States 19123
    2 Qualtex Laboratories San Antonio Texas United States 78201
    3 Eastern Virginia Medical School (EVMS) Norfolk Virginia United States 23507

    Sponsors and Collaborators

    • MP Biomedicals, LLC
    • MP Biomedicals Asia Pacific Pte. Ltd.

    Investigators

    • Principal Investigator: Sara Dionne, PhD, LABS, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    MP Biomedicals, LLC
    ClinicalTrials.gov Identifier:
    NCT03226119
    Other Study ID Numbers:
    • MP-EIA-HTLV-002B
    First Posted:
    Jul 21, 2017
    Last Update Posted:
    Sep 13, 2018
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by MP Biomedicals, LLC
    HTLV
    Confirmatory
    Supplemental
    Blot
    HTLV-I
    HTLV-II
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    HTLV-I Infections
    Paraparesis, Tropical Spastic
    HTLV-II Infections
    Leukemia, T-Cell
    Leukemia-Lymphoma, Adult T-Cell
    Spinal Cord Diseases

    Study Results

    No Results Posted as of Sep 13, 2018