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COMPLETEDPHASE4

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

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))

NCT00467545•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.

Locations (6)

Novartis Investigative Site (705-035)

Daegu, South Korea

Novartis Investigative Site , (420-717)

Gyeonggi-do, South Korea

Novartis Investigative Site , (405-760)

Incheon, South Korea

Novartis Investigative Site , (136-705)

Seoul, South Korea

Novartis Investigative Site , (150-590)

Seoul, South Korea

Novartis Investigative Site

Seoul, South Korea

Key Dates

Start Date

April 1, 2007

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

June 23, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

telbivudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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