[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100153676":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":23,"locations":11,"responsibleParty":29,"collaborators":11,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":11,"studyType":44,"phases":45,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":11},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Combination therapy","EXPERIMENTAL",null,[13],"Biological: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin","HCQ will be taken daily as an oral tablet of 200 mg b.i.d. Pegylated Interferon Alpha-2a - (180 µg) will be administered as weekly subcutaneous (s.c.) injections of 0.5 ml.\n\nRibavirin - will be taken daily based on the patient body weight. If body weight is \\\u003C 75 kg, the total daily dose of Copegus® is 1000 mg, administered as 400 mg (2 tablets of 200 mg, morning intake) and 600 mg (3 tablets of 200 mg, evening intake). If body weight is \\>= 75 kg, the total daily dose is 1200 mg administered as twice 600 mg (3 tablets of 200 mg per intake, morning and evening).",[9],[21,22],"Copegus","Pegasys",[24],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Yaakov Maor, Dr","CONTACT","97235302906","yaakov.maor@sheba.health.gov.il",{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":30,"oldOrganization":5},"Dr. Yaakov Maor","100153676","phase-1-clinical-trial-to-assess-safety-and-efficacy-of-combination-therapy-hydroxychloroquine-pegylated-interferon-alpha-2a-and-ribavirin-in-chronic-hepatitis-c-subjects-non-responders-to-the-standard-of-care-therapy-100153676",false,"NCT01272310","Clinical Trial to Assess Safety and Efficacy of Combination Therapy: Hydroxychloroquine, Pegylated Interferon Alpha-2a and Ribavirin in Chronic Hepatitis C Subjects Non-responders to the Standard of Care Therapy.","A Phase I\u002FII, Open Clinical Trial to Assess the Safety, Tolerability and Efficacy of a Fixed Dose Combination Therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN Alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected Subjects Who Failed to Respond Following a Course of Peg-IFN and RBV Therapy (SoC).","Inclusion Criteria:\n\n1. Males and females between 18 and 70 years old.\n2. Subjects diagnosed to have positive HCV antibodies using a third generation test.\n3. Subject is diagnosed to have detectable HCV RNA by PCR.\n4. Liver biopsy or FibroTest showing a METAVIR score ≥F2 and\u002For ≥A2.\n5. Subject diagnosed to have compensated liver disease.\n6. Subject is non-responder (null or partial) on prior Peg-IFN and RBV based treatment lasting for at least 12 consecutive weeks.\n7. Treatment not discontinued due to intolerability to Peg-IFN or RBV.\n8. Subjects able to comprehend and give informed consent for participation in this study.\n9. Subject is willing to be treated and commit to all visits.\n\nExclusion Criteria:\n\n1. Anti HCV therapy contraindications.\n2. Subject is identified as a relapser on prior Peg-IFN and RBV based treatment.\n3. Hypersensitivity to one of the three drugs (HCQ, Peg-IFN, RBV).\n4. Patient has Anaemia,neutropenia, thrombocytopenia, elevated bilirubin levels, elevated ALT and\u002For AST, or elevated creatinin and INR greater than 1.5.\n5. Concomitant liver disease other than hepatitis C: chronic hepatitis B, alcoholic liver disease, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency.\n6. Decompensated cirrhosis (Child Pugh \\>A).\n7. Clinical evidence for hepatocellular carcinoma.\n8. Human immunodeficiency virus co-infection.\n9. Major uncontrolled psychiatric illness. Minor or situational depressions are allowed.\n10. Active elicit drug or alcohol abuse.\n11. Serious co-morbid conditions as: heart failure, significant coronary heart disease, chronic obstructive pulmonary disease, renal insufficiency, poorly controlled diabetes, autoimmune disorders, and malignant diseases in the previous 5 years.\n12. Immunosuppressive treatment including corticosteroids,\n13. Untreated or uncontrolled or thyroid disease.\n14. Solid transplant organ (renal, heart, or lung).\n15. Pregnancy or unwillingness to practice double contraception or abstinence by the subject of childbearing potential or partner.\n16. Subject objects to the study protocol.\n17. Concurrent participation in any other clinical study within 30 days prior to enrollment.","ALL","18 Years","70 Years",{"count":42,"type":43},36,"ESTIMATED","INTERVENTIONAL",[46,47],"PHASE1","PHASE2","The study is aimed to investigate the safety, tolerability and efficacy of a fixed dose combination therapy of: Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (PEG-IFN alpha-2a) and Ribavirin (RBV) in Chronic Hepatitis C Genotype 1 Infected adult subjects who failed to respond following a course of PEG-IFN and RBV Therapy.",[50],"Chronic Hepatitis C",[50,52,53,54,55,56],"Combination Therapy","Hydroxychloroquine","Pegylated Interferon Alpha-2a","Ribavirin","Chronic Hepatitis C Genotype 1 infected adult subjects","UNKNOWN","2011-01-06",{"date":60,"type":43},"2011-01-07",{"date":62,"type":11},"2011-01",{"date":64,"type":43},"2013-07",{"name":5,"class":6}]