MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Completed · Phase 4

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT03226119

Run by

MP Biomedicals, LLC

People needed

150

Starts

2018-01-15

Expected to finish

2018-08-31

Last updated by the study team

2018-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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