Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: April 6, 2009
Last updated: May 3, 2012
Last verified: May 2012
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
Compensated Chronic Hepatitis B
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||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
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. [ Time Frame: Visit 2 (week 1) ] [ Designated as safety issue: No ]
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 [ Time Frame: weeks 1, 24, 52 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion [ Time Frame: weeks 24, 52 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
- 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) ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877149
|Beijing Ditan Hospital
|Beijing, China |
|Peking University People's Hospital
|Peking, China |
|First Hospital of Peking University
|Peking, China |
|Ruijin Hospital, Affiliated to 2nd Medical university
|Shanghai, China |
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 6, 2009
||May 3, 2012
||China: Food and Drug Administration
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 28, 2014
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action