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Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

Primary Purpose

Chronic Hepatitis B

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

telbivudine

adefovir dipivoxil

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Adults, compensated chronic hepatitis B, telbivudin, aedevofir dipivoxil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Novartis
Novartis
Novartis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

telbivudine

adefovir dipivoxil

Outcomes

Primary Outcome Measures

Efficacy at 24 weeks of treatment.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00606099

First Posted

January 21, 2008

Last Updated

May 1, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00606099

Brief Title

Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Withdrawn

Why Stopped

study was cancelled

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

Adults, compensated chronic hepatitis B, telbivudin, aedevofir dipivoxil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

telbivudine

Arm Title

Arm Type

Active Comparator

Arm Description

adefovir dipivoxil

Intervention Type

Drug

Intervention Name(s)

telbivudine

Intervention Description

To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.

Intervention Type

Drug

Intervention Name(s)

adefovir dipivoxil

Intervention Description

Active Comparator

Primary Outcome Measure Information:

Title

Efficacy at 24 weeks of treatment.

Time Frame

1 yr

Secondary Outcome Measure Information:

Title

Time Frame

1yr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Novartis

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Novartis

City

Flushing

State/Province

New York

ZIP/Postal Code

11355

Country

United States

Facility Name

Novartis

City

Sterling

State/Province

Virginia

ZIP/Postal Code

20166

Country

United States

12. IPD Sharing Statement

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Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

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