MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Phase 4

Completed

• Conditions: HTLV I Associated T Cell Leukemia Lymphoma; HTLV-I Infections; Human T-lymphotropic Virus 1; HTLV I Associated Myelopathies; Human T-lymphotropic Virus 2; HTLV-II Infections
• Interventions: Diagnostic Test: MP Diagnostics HTLV Blot 2.4

• Registration Number: NCT03226119
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Status Verified: 2017-09
• Study Start: 2018-01-15
• Primary Completion: 2018-07-10
• Study Completion: 2018-08-31
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTLV Infected (n=50)	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)	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

Primary Outcome Measures

Name	Time	Method
To demonstrate HTLV Blot 2.4 sensitivity of ≥97.5% in 50 HTLV Known Positive Specimens	3 months
To demonstrate ≥95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens	3 months

Trial Locations

Locations (3)

Qualtex Laboratories; 🇺🇸 San Antonio, Texas, United States

LABS, Inc.; 🇺🇸 Philadelphia, Pennsylvania, United States

Eastern Virginia Medical School (EVMS); 🇺🇸 Norfolk, Virginia, United States