An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT00467545
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests
Trial Locations
- Locations (6)
Novartis Investigative Site , (405-760)
🇰🇷In Cheon, Korea, Republic of
Novartis Investigative Site , (420-717)
🇰🇷Gyeonggi-Do, Korea, Republic of
Novartis Investigative Site (705-035)
🇰🇷Daegu, Korea, Republic of
Novartis Investigative Site , (136-705)
🇰🇷Seoul, Korea, Republic of
Novartis Investigative Site
🇰🇷Seoul, Korea, Republic of
Novartis Investigative Site , (150-590)
🇰🇷Seoul, Korea, Republic of