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An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467545
First Posted: April 30, 2007
Last Update Posted: June 23, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.

Condition Intervention Phase
Chronic Hepatitis B Drug: telbivudine Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension to A Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB) (An Open-label Multicenter, follow-on Trial of the Safety of Oral Administration of Telbivudine (LDT600) 600 mg Over 21 Months in Adults With HBeAg-positive Ompensated Chronic Hepatitis B (CHB))

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety of telbivudine (LDT600) up to 21 additional months of open-label treatment in patients with chronic hepatitis B who have completed study CLDT600A2407 assessed by Adverse Events, data of vital signs and other tests

Secondary Outcome Measures:
  • Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests

Enrollment: 44
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
  • Patient is willing and able to comply with the study drug regimen and all other study requirements
  • The patient is willing and able to provide written informed consent to participate in the extension study.

Exclusion Criteria:

  • Patient is pregnant or breastfeeding.
  • Patient is co-infected with HCV, HDV, or HIV.
  • History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00467545


Locations
Korea, Republic of
Novartis Investigative Site (705-035)
Daegu, Korea, Republic of
Novartis Investigative Site , (420-717)
Gyeonggi-Do, Korea, Republic of
Novartis Investigative Site , (405-760)
In Cheon, Korea, Republic of
Novartis Investigative Site , (136-705)
Seoul, Korea, Republic of
Novartis Investigative Site , (150-590)
Seoul, Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00467545     History of Changes
Other Study ID Numbers: CLDT600AKR02
First Submitted: April 27, 2007
First Posted: April 30, 2007
Last Update Posted: June 23, 2017
Last Verified: May 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HBeAg-positive
chronic hepatitis B
telbivudine

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
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
Entecavir
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action