Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Adefovir; Adefovir dipivoxil; Telbivudine

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.