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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:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00467545
First received: April 27, 2007
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novartis:

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00467545     History of Changes
Other Study ID Numbers: CLDT600AKR02
Study First Received: April 27, 2007
Last Updated: May 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013