Study of Viramidine to Ribavirin in Patients with Chronic Hepatitis C Who Are Treatment Naive

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.

Official Title

Randomized, Double-Blind, Multicenter Study to Compare the Safety and Efficacy of Viramidine to Ribavirin in Treatment-Naive Patients With Chronic Hepatitic C

Conditions

Chronic Hepatitis C

Study Type

Study Type: Interventional

Study Design

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

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)

Study Start

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

Total Enrolment

900

Contact Details

Australia, New South Wales Westmead Hospital, Westmead, New South Wales, 2145, Australia; Recruiting Geoff Farrel 61-2-9845-9006 geoff_farrel@wmi.usyd.edu.au Geoff Farrel, MD, Principal InvestigatorAustralia, South Australia Royal Adelaide Hospital, Adelaide, South Australia, 5000, Australia; Recruiting Hugh Harley 61-8-8332-9977 hharley@mail.rah.sa.gov.au Hugh Harley, MD, Principal InvestigatorAustralia, Victoria Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia; Recruiting Joseph Sasadeusz 61-3-9342-8616 joe.sasadeusz@mh.org.au Joseph Sasadeusz, MD, Principal Investigator The Alfred Hospital, Prahran, Victoria, 3181, Australia; Recruiting Stuart Roberts 61-3-9276-3375 s.roberts@alfred.org.au Stuart Roberts, MD, Principal InvestigatorAustralia, Western Australia Sir Charles Gairdner Hospital, Nedlands, Western Australia, 6009, Australia; Recruiting Gary Jeffrey 618-9346-3228 gjeffrey@cyllene.uwa.edu.au Gary Jeffrey, MD, Principal Investigator