CTRI/2010/091/001114招募中未知
A Pilot Study Using the Aethlon Hemopurifier® in the Treatment of Chronic HCV Infection in Combination with Standard of Care Drug Therapy
Aethlon Medical, Inc.8910 University Center Lane, Suite 660San Diego, CA 921220 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ≥ 60
- •?Must have the following minimum hematologic, biochemical, and serologic criteria documented at least 28-days prior to entry into study:
- •oHemoglobin values of  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.
排除标准
- •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
研究者
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