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

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00467545

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 IV

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Entecavir Telbivudine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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))

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

Estimated Enrollment:	40
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

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

Contacts

Contact: novartis

41613241111

Locations

Korea, Republic of
Novartis Investigative Site	Recruiting
Seoul, Korea, Republic of
Contact: novartis 41613241111
Novartis Investigative Site , (136-705)	Recruiting
Seoul, Korea, Republic of
Contact: Novartis 41613241111
Novartis Investigative Site , (405-760)	Recruiting
In Cheon, Korea, Republic of
Contact: novartis 41643241111
Novartis Investigative Site (705-035)	Recruiting
Daegu, Korea, Republic of
Contact: novartis 41613241111
Novartis Investigative Site , (150-590)	Recruiting
Seoul, Korea, Republic of
Contact: Novartis 41613241111
Novartis Investigative Site , (420-717)	Recruiting
Gyeonggi-Do, Korea, Republic of
Contact: novartis 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLDT600AKR02
Study First Received:	April 27, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00467545
Health Authority:	South Korea: Food and Drug Administration

Keywords provided by Novartis:

HBeAg-positive
chronic hepatitis B
telbivudine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Entecavir
Digestive System Diseases

Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 15, 2009