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

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

ChemIDplus related topics:

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

Investigators


Study Director:	Novartis	Novartis

More Information

Responsible Party:	novartis ( novartis )
Study ID Numbers:	CLDT600AKR02
First Received:	April 27, 2007
Last Updated:	July 3, 2008
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 September 05, 2008

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