Back to resultsAn Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
telbivudine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring HBeAg-positive, chronic hepatitis B, telbivudine
Eligibility 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.
Sites / Locations
- Novartis Investigative Site (705-035)
- Novartis Investigative Site , (420-717)
- Novartis Investigative Site , (405-760)
- Novartis Investigative Site , (136-705)
- Novartis Investigative Site , (150-590)
- Novartis Investigative Site
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00467545
Brief Title
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
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))
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
HBeAg-positive, chronic hepatitis B, telbivudine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
telbivudine
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site (705-035)
City
Daegu
Country
Korea, Republic of
Facility Name
Novartis Investigative Site , (420-717)
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
Novartis Investigative Site , (405-760)
City
In Cheon
Country
Korea, Republic of
Facility Name
Novartis Investigative Site , (136-705)
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site , (150-590)
City
Seoul
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
An Extension to Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
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