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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

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ClinicalTrials.gov Identifier: NCT03226119
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
MP Biomedicals Asia Pacific Pte. Ltd.
Information provided by (Responsible Party):
MP Biomedicals, LLC

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
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 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 Type : Interventional  (Clinical Trial)
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 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 : January 15, 2018
Actual Primary Completion Date : July 10, 2018
Actual Study Completion Date : August 31, 2018


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 Name: 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 Name: HTLV I/II Western Blot Assay




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226119


Locations
United States, Pennsylvania
LABS, Inc.
Philadelphia, Pennsylvania, United States, 19123
United States, Texas
Qualtex Laboratories
San Antonio, Texas, United States, 78201
United States, Virginia
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.

Publications:
Responsible Party: MP Biomedicals, LLC
ClinicalTrials.gov Identifier: NCT03226119     History of Changes
Other Study ID Numbers: MP-EIA-HTLV-002B
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All clinical study data will be compiled and shared with investigators following database lock.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Q4 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by MP Biomedicals, LLC:
HTLV
Confirmatory
Supplemental
Blot
HTLV-I
HTLV-II

Additional relevant MeSH terms:
HTLV-I Infections
HTLV-II Infections
Infection
Communicable Diseases
Leukemia, T-Cell
Spinal Cord Diseases
Paraparesis, Tropical Spastic
Leukemia-Lymphoma, Adult T-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Deltaretrovirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Immunologic Deficiency Syndromes