Back to resultsEfficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
Primary Purpose
Compensated Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
telbivudine/LDT600
Sponsored by
About this trial
This is an interventional treatment trial for Compensated Chronic Hepatitis B focused on measuring Chronic HBV
Eligibility Criteria
Inclusion Criteria:
- Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
- Patient was not discontinued from the previous CLDT600ACN04 study.
- Adult patients with CHB (HBeAg positive or HBeAg negative).
- HBV DNA PCR undetectable in recent 12 months.
Exclusion Criteria:
- Pregnant or breastfeeding, or has plan of pregnant during study period.
- Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
- Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
Other protocol-defined inclusion/exclusion criteria may apply.
Sites / Locations
- Beijing Ditan Hospital
- First Hospital of Peking University
- Peking University People's Hospital
- Ruijin Hospital, Affiliated to 2nd Medical university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
Secondary Outcome Measures
To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment
To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies
To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion
To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00877149
Brief Title
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
Official Title
A Single-arm, Multicenter, Open-label, 52-week Treatment, Extension Study to CLDT600ACN04 Study to Evaluate the Efficacy (Including Histological Improvement) and Safety in Fourth to Sixth Year of Telbivudine Treatment in Patients With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to provide data of absence of inflammation in patient liver histology after long-term telbivudine treatment and thus help investigators to make a comprehensive judgment on treatment discontinuation in selected patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compensated Chronic Hepatitis B
Keywords
Chronic HBV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
telbivudine/LDT600
Primary Outcome Measure Information:
Title
To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
Time Frame
Visit 2 (week 1)
Secondary Outcome Measure Information:
Title
To assess the HBV DNA PCR negativity at 4th-6th year treatment with telbivudine (LDT), in selected patients who have completed study CLDT600ACN04 and will continue telbivudine treatment
Time Frame
weeks 1, 24, 52 and 24 weeks post-treatment
Title
To evaluate the percentage of patients with HBeAg loss and/or gain of detectable level of HBeAb in HBeAg positive CHB at baseline of NV-02B-007 or NV-02B-015 studies
Time Frame
weeks 24 and 52, 24 weeks post-treatment
Title
To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion
Time Frame
weeks 24, 52 and 24 weeks post-treatment
Title
To evaluate the changes in Knodell inflammatory and fibrosis scores from biopsy at study entry compared to biopsy at baseline of studies NV-02B-007 and NV-02B-015
Time Frame
Visit 2 (week 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient completed study CLDT600ACN04 study and will be available to immediately rollover into this study without discontinuation of study drug.
Patient was not discontinued from the previous CLDT600ACN04 study.
Adult patients with CHB (HBeAg positive or HBeAg negative).
HBV DNA PCR undetectable in recent 12 months.
Exclusion Criteria:
Pregnant or breastfeeding, or has plan of pregnant during study period.
Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV at screening visit.
Patient has received within the past 12 months any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Ditan Hospital
City
Beijing
Country
China
Facility Name
First Hospital of Peking University
City
Peking
Country
China
Facility Name
Peking University People's Hospital
City
Peking
Country
China
Facility Name
Ruijin Hospital, Affiliated to 2nd Medical university
City
Shanghai
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26329749
Citation
Hou JL, Xu D, Shi G, Wan M, Goodman Z, Tan D, Xie Q, Chen C, Wei L, Niu J, Wang Q, Ren H, Wang Y, Jia J, Bao W, Dong Y, Trylesinski A, Naoumov NV. Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B. Adv Ther. 2015 Aug;32(8):727-41. doi: 10.1007/s12325-015-0232-2. Epub 2015 Sep 2.
Results Reference
derived
Learn more about this trial
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
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