Study Stopped
study was cancelled
Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B
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
1 other identifier
interventional
N/A
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedMay 2, 2012
May 1, 2012
2 years
January 21, 2008
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy at 24 weeks of treatment.
1 yr
Secondary Outcomes (1)
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
Study Arms (2)
1
EXPERIMENTALtelbivudine
2
ACTIVE COMPARATORadefovir dipivoxil
Interventions
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (3)
Novartis
Atlanta, Georgia, 30308, United States
Novartis
Flushing, New York, 11355, United States
Novartis
Sterling, Virginia, 20166, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 1, 2008
Study Start
November 1, 2007
Primary Completion
November 1, 2009
Last Updated
May 2, 2012
Record last verified: 2012-05