MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

HTLV-I Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226119
• Other study ID #: MP-EIA-HTLV-002B
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2017
• Source: MP Biomedicals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 31, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HTLV I Associated Myelopathies
• HTLV I Associated T Cell Leukemia Lymphoma
• HTLV-I Infections
• HTLV-II Infections
• Human T-lymphotropic Virus 1
• Human T-lymphotropic Virus 2
• Infection
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Spinal Cord Diseases

Intervention

Diagnostic Test:
• MP Diagnostics HTLV Blot 2.4
HTLV I/II Confirmation and Differentiation

Locations

Country	Name	City	State
United States	Eastern Virginia Medical School (EVMS)	Norfolk	Virginia
United States	LABS, Inc.	Philadelphia	Pennsylvania
United States	Qualtex Laboratories	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
MP Biomedicals, LLC	MP Biomedicals Asia Pacific Pte. Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate =95% agreement of HTLV Blot 2.4 results with the Reference Core Laboratory HTLV Algorithm in 100 Neurological Disorder Specimens		3 months
Primary	To demonstrate HTLV Blot 2.4 sensitivity of =97.5% in 50 HTLV Known Positive Specimens		3 months