Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

A 26 Week Randomized, Open Label, Multi-center Study of the Efficacy and Safety of Telbivudine 600 mg Once Daily Versus Adefovir Dipivoxil 10mg Once Daily in Subjects With Compensated Chronic Hepatitis B and Sub-optimal Response to at Least 48 Weeks of Adefovir Dipivoxil 10 mg

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00606099
• Other study ID #: CLDT600AUS03
• Status: Withdrawn
• Phase: Phase 4
• First received: January 21, 2008
• Last updated: May 1, 2012
• Start date: November 2007

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• telbivudine
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
• adefovir dipivoxil
Active Comparator

Locations

Country	Name	City	State
United States	Novartis	Atlanta	Georgia
United States	Novartis	Flushing	New York
United States	Novartis	Sterling	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy at 24 weeks of treatment.		1 yr
Secondary	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