Status:
UNKNOWN
Treatment of Chronic HCV Infected Egyptian Patients With Electromagnetic Waves and Herbal Therapy
Lead Sponsor:
Egyptian Military Medical Services
Collaborating Sponsors:
EMS
Conditions:
Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief Summary
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 su...
Detailed Description
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 supplemen...
Eligibility Criteria
Inclusion
- 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/m2.
- 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.
Exclusion
- History of severe, life-threatening or other significant sensitivity to any drug.
- Females who are pregnant or breast feeding.
- Recent (within 6-months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol.
- Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (anti-HIV Ab).
- 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.
- History of uncontrolled seizures, cancer, or uncontrolled diabetes, as defined by a HbA1C level \>8.0%.
- Any current or past clinical evidence of cirrhosis , a history or presence of ascites, oesophageal varices, or hepatic encephalopathy.
- Known cause of liver disease other than chronic HCV infection.
- 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\<lower limit of normal (LLN),
- Prothrombin time INR \> 1.5,
- Haemoglobin \< 11 %,
- Platelets\<120,000cellsper mm3
- Absolute neutrophil count \<1500cells/µL,
- Total bilirubin\> 1.5 mg/dL,
- Clinically significant abnormal echocardiography or ECG.
- Any contraindications to central venous catheter insertion.
- Previous history of photosensitivity, skin cancer or presence of a positive family history of Skin Cancer.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02215525
Start Date
April 1 2014
End Date
May 1 2015
Last Update
August 13 2014
Active Locations (1)
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1
EMMS
Cairo, Heliopolis, Egypt, 11613