Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- sustained virological response (SVR) at 12 weeks
研究概览
简要总结
A Randomized, Open-Label, Study to evaluate and compare the efficacy and safety, of extracorporeal irradiation of circulating blood by UVA with antioxidant as a supplement (Selenium containing food supplement herbal tablets) in the treatment of non-cirrhotic subjects with chronic hepatitis C.
详细描述
Objectives: To evaluate and compare the Efficacy and Safety, of extra-corporeal irradiation of circulating blood by extra-corporeal electro-magnetic irradiation with Selenium containing food supplement herbal tablets in the treatment of non-cirrhotic subjects with chronic hepatitis C.
Background and Rationale: As many as 150 million persons are chronically infected with the hepatitis C virus (HCV) worldwide, and more than 350,000 die annually from liver disease caused by HCV
Egypt is confronted with an HCV disease burden of historical proportions that distinguishes this nation from others. It has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7% . Approximately, there are 10 million Egyptians carry the virus. Due to its chronic debilitating nature, it has tremendous social and financial impacts on our community. Hence, this trial aims to find a logic rational and effective treatment for Hepatitis C.
Extra-corporeal electro-magnetic irradiation: The wavelength of UV irradiation (UVI) lies in the range of 100-400 nm, and is further subdivided into UVA (315-400 nm), UVB (280-315 nm), and UVC (100-280 nm).UVC and UVB are directly absorbed by DNA bases causing serious DNA damages. On the other hand, DNA damage by UVA is indirect through the formation of Reactive Oxygen Species (ROS) that are formed when other cellular chromophores act as endogenous photo sensitizers. ROS can then react with and damage DNA, or interact with other cell structures such as membranes (lipids) and proteins. All of these different types of damage may hamper cell metabolic processes, such as protein synthesis and cell cycle progression, or induce mutations and cell death . Both Selenium itself and various selenoproteins are proposed to have antioxidant effects, reducing the biological impact of ROS on human cells .
Ultraviolet blood irradiation (UBI) was first used on humans in the early 1930s. The effectiveness of UBI in treating infections was studied extensively in the 1940s and it was found that UBI was extremely successful in treating such infections as peritonitis, pyelitis, sinusitis, puerperal sepsis and wound infections in all but the most advanced cases.Later studies showed UBI helped a number of patients with acute viral hepatitis .Recently, Energex Systems, a developer of advanced UBI technology, studied the effects of UBI therapy on viral loads in 13 patients with the infection and it showed some effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age of 21 and 60 years.
- •Female subjects of childbearing potential must be willing to use effective form of birth control.
- •Sexually active fertile females in childbearing period must have negative results for pregnancy tests.
- •Sexually active fertile males must agree either him or his wife to practicing effective form of birth control.
- •Subject should be treatment: Non cirrhotic HCV chronic Hepatitis.
- •Subjects must be able to understand and to adhere to the study visits schedule.
- •Body mass index (BMI) is >18 to <35kg/m
- •Must voluntarily sign and date an informed consent, approved by an Institutional Review Board/Ethics Committee (IRB/EC), prior to the initiation of any study-specific procedures.
- •Chronic HCV for at least 6 months prior to study enrolment. Chronic HCV infection is defined as one of the following:
- •Positive for anti-HCV antibody or HCV RNA at least 6 months before Screening, and positive for HCV RNA and anti-HCV antibody at the time of Screening; OR
- •Positive for anti-HCV antibody and HCV RNA at the time of Screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrolment with evidence of chronic hepatitis C disease).
- •Absence of cirrhosis judged by documented results of :-
- •Liver Ultrasound. OR
- •Fibro Test score of ≤ 0.75 and Aspartate Amino transferase to Platelet Ratio Index (APRI) ((AST/AST ULN)X100)/Plt in thousands) ≤ 2 at Screening, OR
- •FibroScan® result of <14.5kPa, OR
- •The absence of cirrhosis based on a liver biopsy within the last 36months.
- •If the rewire multiple assessments on the same date for a subject, fibrosis score was calculated in the order of liver biopsy, FibroScan, and Fibro Test. If the rewire assessments on different dates for a subject by different methods, fibrosis score was calculated n the order of liver biopsy, FibroScan, and Fibro Test. If the rewire assessments on different dates for a subject by the same method, fibrosis score was calculated by maximum value.
- •Subject has a plasma HCV RNA level >10,000 International Units (IU)/mLat screening.
排除标准
- •1. History of severe, life-threatening or other significant sensitivity to any drug.
- •2. Females who are pregnant or breast feeding.
- •3. Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
- •4. Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (anti-HIV Ab).
- •5. Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, a 12-lead electrocardiogram (ECG) and echocardiography that make the subject an unsuitable candidate for this study in the opinion of the Investigator.
- •6. History of uncontrolled seizures, cancer, or uncontrolled diabetes, as defined by a HbA1C level \>8.0%.
- •7. Any current or past clinical evidence of cirrhosis , a history or presence of ascites, oesophageal varices, or hepatic encephalopathy.
- •8. Known cause of liver disease other than chronic HCV infection.
- •9. Screening laboratory analyses show any of the following abnormal laboratory results:
- •* Alanine amino transferase (ALT) \>5X upper limit of normal (ULN),
- •* Aspartate amino transferase (AST) \>5X upper limit of normal (ULN),
- •* Calculated creatinine clearance (using Cockcroft-Gault method) \<50mL/min,
- •* Albumin\ 1.5,
- •* Haemoglobin \< 11 %,
- •* Platelets\<120,000cellsper mm3
- •* Absolute neutrophil count \<1500cells/µL,
- •* Total bilirubin\> 1.5 mg/dL,
- •10. Clinically significant abnormal echocardiography or ECG.
- •11. Any contraindications to central venous catheter insertion.
- •12. Previous history of photosensitivity, skin cancer or presence of a positive family history of Skin Cancer.
结局指标
主要结局
sustained virological response (SVR) at 12 weeks
时间窗: 12 weeks after the end of treatment
SVR is defined as an absence of detectable HCV RNA in the serum with use of an assay with a sensitivity of at least 50 IU/mL.
次要结局
- Sustained Virological Response (SVR) at 24 weeks(24 weeks after completion of the course of treatment.)