Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Launched by NOVARTIS · Jan 31, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, at least 18 years of age.
• • Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
• • Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
• • Patient is willing to comply with all study requirements.
• • Patient is willing and able to provide written informed consent.
• Exclusion Criteria:
• • Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit.
• • Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
• • Patient is co-infected with hepatitis C virus or HIV.
• • Patient has previously taken lamivudine.
• • Patient is currently abusing illicit drugs or alcohol.
• • Patient is using any investigational drugs or with in the last 30 days.
• • Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
• • Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
• • Other protocol-defined inclusion/exclusion criteria may apply.