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Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00606099
Recruitment Status : Withdrawn (study was cancelled)
First Posted : February 1, 2008
Last Update Posted : May 2, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: telbivudine Drug: adefovir dipivoxil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  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. [ Time Frame: 1yr ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00606099

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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
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Responsible Party: Novartis Identifier: NCT00606099    
Other Study ID Numbers: CLDT600AUS03
First Posted: February 1, 2008    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012
Keywords provided by Novartis:
compensated chronic hepatitis B
aedevofir dipivoxil
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, 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