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Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

This study has been withdrawn prior to enrollment.
(study was cancelled)
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 21, 2008
Last updated: May 1, 2012
Last verified: May 2012
This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic hepatitis B.

Condition Intervention Phase
Chronic Hepatitis B Drug: telbivudine Drug: adefovir dipivoxil Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy at 24 weeks of treatment. [ Time Frame: 1 yr ]

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. [ Time Frame: 1yr ]

Enrollment: 0
Study Start Date: November 2007
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: telbivudine
To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.
Active Comparator: 2
adefovir dipivoxil
Drug: adefovir dipivoxil
Active Comparator


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations
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Please refer to this study by its identifier: NCT00606099

United States, Georgia
Atlanta, Georgia, United States, 30308
United States, New York
Flushing, New York, United States, 11355
United States, Virginia
Sterling, Virginia, United States, 20166
Sponsors and Collaborators
  More Information

Responsible Party: Novartis Identifier: NCT00606099     History of Changes
Other Study ID Numbers: CLDT600AUS03
Study First Received: January 21, 2008
Last Updated: May 1, 2012

Keywords provided by Novartis:
compensated chronic hepatitis B
aedevofir dipivoxil

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents processed this record on August 17, 2017