MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

September 12, 2018 updated by: MP Biomedicals, LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19123
        • LABS, Inc.
    • Texas
      • San Antonio, Texas, United States, 78201
        • Qualtex Laboratories
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School (EVMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months
To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MP Biomedicals, LLC

Collaborators

MP Biomedicals Asia Pacific Pte. Ltd.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2018

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

July 19, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2018

Last Update Submitted That Met QC Criteria

September 12, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MP-EIA-HTLV-002B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All clinical study data will be compiled and shared with investigators following database lock.

IPD Sharing Time Frame

Q4 2017

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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