<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02215902</url>
  </required_header>
  <id_info>
    <org_study_id>AEMD - IDE - 2013</org_study_id>
    <nct_id>NCT02215902</nct_id>
  </id_info>
  <brief_title>Safety Study of the Aethlon Hemopurifier</brief_title>
  <acronym>AEMD-IDE-20</acronym>
  <official_title>A Clinical Safety Study of the Aethlon Hemopurifier® in Chronic ESRD Patients With HCV Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aethlon Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aethlon Medical Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
      To demonstrate the safety of the Aethlon Hemopurifier® when used in extracorporeal blood&#xD;
      purification.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To quantify the number of viral copies captured by the Aethlon Hemopurifier® during the first&#xD;
      and last Hemopurifier treatments using elution methods developed by Aethlon Medical Inc.&#xD;
&#xD;
      To measure changes in viral load in patients before and after treatment with the Aethlon&#xD;
      Hemopurifier®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single-arm, sequential, controlled feasibility/safety study in which each&#xD;
      subject will serve as his/her own control. The control period will be the week immediately&#xD;
      preceding the use of the investigational device during which eligible subjects will undergo&#xD;
      and be monitored during three standard intermittent dialysis sessions. Vital signs, blood&#xD;
      chemistries, hematology, liver function and adverse events will be measured. On weeks two and&#xD;
      three, patients will receive treatment with the Hemopurifier® three times per week coincident&#xD;
      with their ongoing standard intermittent hemodialysis treatments. During these two weeks,&#xD;
      subjects will be assessed for the same clinical parameters but with the addition of viral&#xD;
      load determination by quantitative PCR before and after each treatment with the&#xD;
      Hemopurifier®. Viral load will also be measured at follow-up prior to the start of a given&#xD;
      subject's hemodialysis treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Adequate safety data has been accumulated and the # of patients meeting inclusion criteria has&#xD;
    diminished.&#xD;
  </why_stopped>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 10, 2017</completion_date>
  <primary_completion_date type="Actual">March 10, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of adverse events</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Viral load reduction</measure>
    <time_frame>2 weeks</time_frame>
    <description>Viral load will be measured before and after each treatment with the investigational device.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quantification of viral copies captured.</measure>
    <time_frame>2 weeks</time_frame>
    <description>The number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments will be quantified.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>End Stage Renal Disease</condition>
  <condition>Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>Hemopurifier</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Affinity plasmapheresis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Affinity plasmapheresis</intervention_name>
    <description>Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.</description>
    <arm_group_label>Hemopurifier</arm_group_label>
    <other_name>Aethlon Medical Hemopurifier</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males or females 18 years of age and older.&#xD;
&#xD;
          2. Positive test for HCV infection (any genotype).&#xD;
&#xD;
          3. End-stage-renal disease (ESRD) requiring dialysis - already established on HD.&#xD;
&#xD;
          4. The arteriovenous fistula, graft or central venous catheter must have been functioning&#xD;
             adequately for at least 1 month before entry into study showing no signs of infection&#xD;
             or blockage.&#xD;
&#xD;
          5. Have recovered from the toxicity of any prior systemic therapy.&#xD;
&#xD;
          6. Ability to tolerate blood volume losses of up to 150 ml per week, i.e. 50 ml each.&#xD;
&#xD;
          7. Stable clinical condition, including stable hemoglobin which has not fluctuated more&#xD;
             than 1.5 -2.0 gm/dl within 28 days prior to enrollment into study.&#xD;
&#xD;
          8. Must have the following minimum hematologic, biochemical, and serologic criteria&#xD;
             documented within 28 days prior to enrollment into study:&#xD;
&#xD;
               1. Hemoglobin values of ≥ 9.5 gm/dL for males and females&#xD;
&#xD;
               2. Platelet count &gt; 100,000/mm3&#xD;
&#xD;
               3. Bilirubin &lt; 4 mg/dL&#xD;
&#xD;
               4. Albumin stable and not less than 3.5 g/dl.&#xD;
&#xD;
          9. Women of child-bearing potential must be practicing barrier or oral contraception for&#xD;
             the duration of the study or documented as surgically sterile or one year&#xD;
             post-menopausal.&#xD;
&#xD;
         10. If female, be non-nursing, non-pregnant and have a negative serum or urine pregnancy&#xD;
             test within two weeks of starting study.&#xD;
&#xD;
         11. The subject must be informed of the investigational nature of this study and written&#xD;
             informed consent obtained prior to enrollment in this study.&#xD;
&#xD;
         12. The subject must be able to comprehend the study description and its nature as only a&#xD;
             feasibility study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Administration of Pegasys-ribavirin or ANY anti-viral drug therapy within 90 days&#xD;
             prior to enrollment into study.&#xD;
&#xD;
          2. Administration of any other investigational drugs within 90 days prior to enrollment&#xD;
             into study.&#xD;
&#xD;
          3. Clinically significant infection, other than HCV, defined as any acute or chronic&#xD;
             viral, bacterial, or fungal infection, which requires specific therapy&#xD;
             (Anti-infectious therapy must have been completed at least 14-days before entry into&#xD;
             study) in order to make entry into the study possible.&#xD;
&#xD;
          4. Patient infected with human immunodeficiency virus or has AIDS.&#xD;
&#xD;
          5. A history of hypotensive episodes during dialysis which lead to early termination of&#xD;
             the treatment in the 2 treatments prior to the start of study treatments.&#xD;
&#xD;
          6. Patients who have received an ACE (angiotensin converting enzyme) inhibitor within the&#xD;
             last 24 hours should not be treated. Patients receiving an ACE inhibitor may&#xD;
             experience an anaphylactoid-like reaction, including hypotension associated with&#xD;
             flushing, dyspnea, and bradycardia. Such reactions, if left untreated, may be&#xD;
             life-threatening. The administration of ACE inhibitors also has been associated with&#xD;
             the occurrence of tachycardia. Risk of an anaphylactoid-like reaction or tachycardia&#xD;
             may be minimized by the temporary cessation of the administration of ACE inhibitors&#xD;
             for 6 days or longer before initiating the treatment protocol.&#xD;
&#xD;
          7. Any known pre-existing medical condition that could interfere with the subject's&#xD;
             participation in the entire protocol, including serious psychiatric disorders, CNS&#xD;
             trauma or active seizure disorders requiring medication, poorly-controlled diabetes&#xD;
             mellitus as indicated by an Hb-A1c &gt; 8% within the two weeks prior to protocol&#xD;
             initiation, significant cardiovascular dysfunction within the past 6 months (e.g.,&#xD;
             angina, congestive heart failure, recent myocardial infarction, severe interdialytic&#xD;
             hypotension, or significant arrhythmia).&#xD;
&#xD;
          8. Subjects with ECG showing clinically significant abnormalities.&#xD;
&#xD;
          9. Dementia or other cognitively-limiting disease processes which would make it difficult&#xD;
             for the patient to articulate their clinical status.&#xD;
&#xD;
         10. Prior blood transfusion for any reason within 3 months prior to enrollment into study.&#xD;
&#xD;
         11. Recent history of bleeding or bleeding disorders that would likely require the&#xD;
             restriction in use of heparin during study treatments.&#xD;
&#xD;
         12. Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's&#xD;
             disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia&#xD;
             purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia,&#xD;
             scleroderma, severe psoriasis).&#xD;
&#xD;
         13. Any medical condition requiring, or likely to require during the course of the study,&#xD;
             chronic systemic administration of steroids or other immunoregulatory medications.&#xD;
&#xD;
         14. Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the&#xD;
             subject has a history of substance abuse, to be considered for inclusion into the&#xD;
             protocol, the subject must have abstained from using the abused substance for at least&#xD;
             2 months. Subjects receiving methadone within the past year are also excluded.)&#xD;
&#xD;
         15. Any cancer requiring systemic chemotherapy or radiotherapy.&#xD;
&#xD;
         16. Any other condition that, in the opinion of the Principal Investigators, would make&#xD;
             the subject unsuitable for enrollment, or could interfere with the subject&#xD;
             participating in and completing the protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Felicia B Ricks, RD CS-R LD</last_name>
    <role>Study Director</role>
    <affiliation>DaVita Clincal Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ronald Ralph, M. D. FASN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kidney Associates, PLLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DaVita Med Center Dialysis</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 13, 2017</last_update_submitted>
  <last_update_submitted_qc>March 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ESRD</keyword>
  <keyword>Hepatitis C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 28, 2020</submitted>
    <returned>September 16, 2020</returned>
    <submitted>October 9, 2020</submitted>
    <returned>October 30, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02215902
org study id: AEMD - IDE - 2013
nct id: NCT02215902
lead sponsor: 
has dmc: No
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®.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of adverse events
time frame: 30 days
measure: Viral load reduction
time frame: 2 weeks
description: Viral load will be measured before and after each treatment with the investigational device.
measure: Quantification of viral copies captured.
time frame: 2 weeks
description: The number of viral copies captured by the Aethlon Hemopurifier® during the first and last Hemopurifier treatments will be quantified.
arm group label: Hemopurifier
arm group type: Experimental
description: Affinity plasmapheresis
intervention type: Device
intervention name: Affinity plasmapheresis
description: Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.
arm group label: Hemopurifier
other name: Aethlon Medical Hemopurifier
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Felicia B Ricks, RD CS-R LD
role: Study Director
affiliation: DaVita Clincal Research
last name: Ronald Ralph, M. D. FASN
role: Principal Investigator
affiliation: Kidney Associates, PLLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided
submitted: August 28, 2020
returned: September 16, 2020
submitted: October 9, 2020
returned: October 30, 2020