MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

MP Biomedicals

Status and phase: Completed; Phase 4

Conditions: HTLV-I Infections; Human T-lymphotropic Virus 1; Human T-lymphotropic Virus 2; HTLV I Associated T Cell Leukemia Lymphoma; HTLV I Associated Myelopathies; HTLV-II Infections

Treatments: Diagnostic Test: MP Diagnostics HTLV Blot 2.4

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03226119

MP-EIA-HTLV-002B

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

HTLV Infected (n=50)

Experimental group

Description:

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

Treatment:

Diagnostic Test: MP Diagnostics HTLV Blot 2.4

Neurological Disorders (n=100)

Experimental group

Description:

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

Treatment:

Diagnostic Test: MP Diagnostics HTLV Blot 2.4