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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Primary Purpose

HTLV-I Infections, HTLV-II Infections, Human T-lymphotropic Virus 1

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

MP Diagnostics HTLV Blot 2.4

About this trial

This is an interventional diagnostic trial for HTLV-I Infections focused on measuring HTLV, Confirmatory, Supplemental, Blot, HTLV-I, HTLV-II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

LABS, Inc.
Qualtex Laboratories
Eastern Virginia Medical School (EVMS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

HTLV Infected (n=50)

Neurological Disorders (n=100)

Arm Description

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

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

Outcomes

Primary Outcome Measures

To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens

To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens

Secondary Outcome Measures

Full Information

NCT ID

NCT03226119

First Posted

July 19, 2017

Last Updated

September 12, 2018

Sponsor

MP Biomedicals, LLC

Collaborators

MP Biomedicals Asia Pacific Pte. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03226119

Brief Title

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Official Title

HTLV Blot 2.4 Post-Market Clinical Study of Neurological Disorders and HTLV Positive Specimens

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 15, 2018 (Actual)

Primary Completion Date

July 10, 2018 (Actual)

Study Completion Date

August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MP Biomedicals, LLC

Collaborators

MP Biomedicals Asia Pacific Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Cohort A: 100 Neurological Disorder Specimens Cohort B: 50 HTLV Known Positive Specimens

Masking

Investigator

Masking Description

Clinical Sites and the Reference Core-Lab will be masked of specimen disease state

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HTLV Infected (n=50)

Arm Type

Experimental

Arm Description

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

Arm Title

Neurological Disorders (n=100)

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

MP Diagnostics HTLV Blot 2.4

Other Intervention Name(s)

HTLV I/II Western Blot Assay

Intervention Description

HTLV I/II Confirmation and Differentiation

Primary Outcome Measure Information:

Title

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

Title

To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Dionne, PhD

Organizational Affiliation

LABS, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

LABS, Inc.

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19123

Country

United States

Facility Name

Qualtex Laboratories

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78201

Country

United States

Facility Name

Eastern Virginia Medical School (EVMS)

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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

IPD Sharing Time Frame

Q4 2017

Citations:

PubMed Identifier

26589659

Citation

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.

Results Reference

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MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

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