Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Phase 4

Withdrawn

• Conditions: Chronic Hepatitis B
• Interventions: Drug: adefovir dipivoxil; Drug: telbivudine

• Registration Number: NCT00606099
• Lead Sponsor: Novartis

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-01-31
• Study First Posted: 2008-02-01
• Primary Completion: 2009-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	adefovir dipivoxil	adefovir dipivoxil
1	telbivudine	telbivudine

Primary Outcome Measures

Name	Time	Method
Efficacy at 24 weeks of treatment.	1 yr

Secondary Outcome Measures

Name	Time	Method
To compare biochemical response at week 24 of treatment. To compare changes in viral load at week 24 of treatment. To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.	1yr

Trial Locations

Locations (1)

Novartis; 🇺🇸 Sterling, Virginia, United States