Safety Study of the Aethlon Hemopurifier (AEMD-IDE-20)
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|ClinicalTrials.gov Identifier: NCT02215902|
Recruitment Status : Terminated (Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has diminished.)
First Posted : August 13, 2014
Last Update Posted : March 14, 2017
To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood purification.
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®.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Hepatitis C Infection||Device: Affinity plasmapheresis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||March 10, 2017|
|Actual Study Completion Date :||March 10, 2017|
Device: Affinity plasmapheresis
Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.
Other Name: Aethlon Medical Hemopurifier
- Rate of adverse events [ Time Frame: 30 days ]
- Viral load reduction [ Time Frame: 2 weeks ]Viral load will be measured before and after each treatment with the investigational device.
- Quantification of viral copies captured. [ Time Frame: 2 weeks ]The number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments will be quantified.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215902
|United States, Texas|
|DaVita Med Center Dialysis|
|Houston, Texas, United States, 77004|
|Study Director:||Felicia B Ricks, RD CS-R LD||DaVita Clincal Research|
|Principal Investigator:||Ronald Ralph, M. D. FASN||Kidney Associates, PLLC|