Dual Algorithm Post Market Clinical Study

Charlotte, NC

N/A

Waitlist Available

Led By Susan Stramer, Ph.D

Research Sponsored by MP Biomedicals, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

The purpose of this study is to assess the validity and reproducibility of the MP Diagnostics HTLV Blot 2.4 in blood specimens testing repeat reactive (RR) on the first FDA licensed screening assay (Abbott Prism) and non-reactive (NR) on the second FDA licensed screening assay (Avioq ELISA).

See full description

Eligible Conditions

HTLV-II Infection
HTLV-1 Infection
Human T-cell Leukemia Virus Infections
Human T-Lymphotropic Virus
Adult T-Cell Leukemia/Lymphoma
Myelopathy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the HTLV dual algorithm testing in blood donor facilities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HTLV Repeat Reactive (RR) / Non Reactive (NR)Experimental Treatment1 Intervention

Blood donor specimens that tested repeat reactive on the first FDA licensed HTLV screening assay and non-reactive on the second FDA licensed HTLV screening assay

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MP Diagnostics HTLV Blot 2.4

2018

Completed Phase 4

~250

Do I qualify?Apply below to find out