The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.
Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitic C
Chronic Hepatitis C
Study Type: Interventional
Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)
Eligibility & Criteria
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both Inclusion Criteria:Treatment-naive patients with compensated chronic hepatitis C. HCV RNA >2000 copies/mL (780 IU/mL) as determined by NGI SuperQuant serum HCV RNA quantification, with a lower limit of detection of 100 copies/mL (39 IU/mL). Exclusion Criteria:Severe neuropsychiatric disorders History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic heart disease, significant or unstable heart disease, gastrointestinal, neurological, renal, urological, endocrine, ophthalmologic disorders including severe retinopathy, or immune mediated disease Pregnant or breast-feeding patients
Australia, New South Wales Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting Geoff Farrel 61-2-9845-9006 email@example.com Geoff Farrel, MD, Principal InvestigatorAustralia, South Australia Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Recruiting Hugh Harley 61-8-8332-9977 firstname.lastname@example.org Hugh Harley, MD, Principal InvestigatorAustralia, Victoria Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia; Recruiting Joseph Sasadeusz 61-3-9342-8616 email@example.com Joseph Sasadeusz, MD, Principal Investigator The Alfred Hospital, Prahran, Victoria, 3181, Australia; Recruiting Stuart Roberts 61-3-9276-3375 firstname.lastname@example.org Stuart Roberts, MD, Principal InvestigatorAustralia, Western Australia Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting Gary Jeffrey 618-9346-3228 email@example.com Gary Jeffrey, MD, Principal Investigator
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