Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
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This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
Study Start Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Documented clinical history compatible with chronic hepatitis C and compensated liver disease
Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
Other protocol-defined inclusion criteria may apply.
Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis B or HIV
Other protocol-defined exclusion criteria may apply.