None listed
Conditions
Interventions
Intervention1: Hemopurifier Device: subjects will receive up to Two-6 hour Hemopurifier®
treatments for up to three days in combination with standard of care drug therapy, followed by drug therapy alone for up to 47-additional weeks.
Control Intervention1: Standard Care: According to Inve
Sponsors
Aethlon Medical, Inc.
8910 University Center Lane, Suite 660
San Diego, CA 92122
Qualtran LLC
Suite No 347, Tower B
Spazedge Business Park
Main Sohna Road, Gurgaon
Haryana (India) 122002
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria ?Males and females 18 years of age and older ?Not on Pegasys-ribavirin or equivalent currently or within past 28 days ?Have received no other investigational drugs within 28-days before entry into study ?Have recovered from the toxicity of any prior systemic therapy ?Study subjects must be willing to submit to temporary vascular access catheterization through the subclavian, jugular or femoral vein. Catheter must be demonstrated to provide adequate blood flow 300 ml/min) during the course of the studies. ?Ability to tolerate blood volume losses of up to 150 ml per week. ?Stable clinical condition, including stable hematocrit. ?Karnofsky score &#8805; 60 ?Must have the following minimum hematologic, biochemical, and serologic criteria documented at least 28-days prior to entry into study: oHemoglobin values of &#61619; 8 gm/dL for males and females oPlatelet count > 100,000/mm3 oBilirubin < 4 mg/dL oAlbumin stable and within normal limits ?Men and women of child-bearing potential must be practicing barrier or oral contraception, for the duration of the study, or documented as surgically sterile or one year post-menopausal ?If female, be non-nursing, non-pregnant and have a negative serum or urine pregnancy test within two weeks of starting study. ?The subject must be informed of the investigational nature of this study and written informed consent obtained prior to enrollment in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria ?Clinically significant infection, other than HCV, defined as any acute viral, bacterial, or fungal infection, which requires specific therapy (Anti-infectious therapy must have been completed at least 14-days before entry into study). ?Received any investigational agent(s) within 28-days of entry into study ?Any known pre-existing medical condition that could interfere with the subject's participation in the protocol, including serious psychiatric disorders, CNS trauma or active seizure disorders requiring medication, poorly controlled diabetes mellitus, significant cardiovascular dysfunction within the past 6 months (e.g., angina, congestive heart failure, recent myocardial infarction, severe hypotension, or significant arrhythmia) ?Subjects with ECG showing clinically significant abnormalities ?Need for frequent blood transfusions. ?Recent History of bleeding or bleeding disorders requiring the restriction in use of anti-coagulants during study treatments. ?Active immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease, ulcerative colitis], rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune or inherited hemolytic anemia, scleroderma, severe psoriasis). ?Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids or other immunoregulatory medications ?Substance abuse, such as alcohol (~80 gm/day), IV drugs, and inhaled drugs (If the subject has a history of substance abuse, to be considered for inclusion into the protocol, the subject must have abstained from using the abused substance for at least 2 months. Subjects receiving methadone within the past year are also excluded.) ?Any cancer requiring systemic chemotherapy ?Any other condition that, in the opinion of the Principal Investigators, would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?Decreases in circulating HCV (qPCR) viral load of &#8805;50% by the end Hemopurifier treatments when compared to viral load prior to initiation of therapy.Timepoint: ?Undetectable HCV viral load in less than 30 days or greater than 100 fold drop in HCV viral load in three months after initiation of drug therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| ?SVR as indicated by undetectable HCV viral load measured six months after the completion of drug therapy ?Acceptable Incidence of unanticipated adverse device events throughout and following experimental treatment ?Incidence and occurrence of adverse events during the course of study or follow up assessments. ?Clinically acceptable changes in hematology or blood chemistry during treatment ?Undetectable levels of GNA or insignificant increases in soluble silica in the bloodTimepoint: ?SVR as indicated by undetectable HCV viral load measured six months after the completion of drug therapy. ?Acceptable Incidence of unanticipated adverse device events throughout and following experimental treatment. ?Incidence and occurrence of adverse events during the course of study or follow up assessments. ?Clinically acceptable changes in hematology or blood chemistry during treatment | — |
Countries
India
Contacts
Public ContactAnuj Sarin
Regd. No. DMC-1690
Outcome results
None listed