Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT02215902
Status:
TERMINATED
Last Update Posted:
2017-03-14
First Post:
2014-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of the Aethlon Hemopurifier
Sponsor:
Aethlon Medical Inc.
Organization:
Study Overview
Official Title:
A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEMD-IDE-20
Brief 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®.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: