NCT02215902

Safety Study of the Aethlon Hemopurifier

A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Aethlon Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives: To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification. Secondary Objectives: To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc. To measure changes in viral load in patients before and after treatment with the Aethlon Hemopurifier®.

Detailed description

This will be a single-arm, sequential, controlled feasibility/safety study in which each subject will serve as his/her own control. The control period will be the week immediately preceding the use of the investigational device during which eligible subjects will undergo and be monitored during three standard intermittent dialysis sessions. Vital signs, blood chemistries, hematology, liver function and adverse events will be measured. On weeks two and three, patients will receive treatment with the Hemopurifier® three times per week coincident with their ongoing standard intermittent hemodialysis treatments. During these two weeks, subjects will be assessed for the same clinical parameters but with the addition of viral load determination by quantitative PCR before and after each treatment with the Hemopurifier®. Viral load will also be measured at follow-up prior to the start of a given subject's hemodialysis treatment.

Conditions

• End Stage Renal Disease
• Hepatitis C Infection

Interventions

Type	Name	Description
DEVICE	Affinity plasmapheresis	Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-03-10
• Completion: 2017-03-10
• First posted: 2014-08-13
• Last updated: 2017-03-14

Locations

1 site across 1 country: United States