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.
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 May 19, 2013
Hepatitis B, Chronic
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
DNA Virus Infections