Efficacy and Safety of Telbivudine in Patients With Chronic Hepatitis B

This study has been withdrawn prior to enrollment.
(study was cancelled)
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00606099
First received: January 21, 2008
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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: 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
telbivudine
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606099

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00606099     History of Changes
Other Study ID Numbers: CLDT600AUS03
Study First Received: January 21, 2008
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Adults
compensated chronic hepatitis B
telbivudin
aedevofir dipivoxil

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B, Chronic
Hepatitis, Chronic
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on September 22, 2014