Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Novartis

Status and phase

Withdrawn

Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: adefovir dipivoxil

Drug: telbivudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00606099

CLDT600AUS03

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.