Clinical trial NCT00877149: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Compensated Chronic Hepatitis B
Keywords: Chronic HBV
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-07
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: To assess proportion of patients with absence of inflammation in liver biopsy at study entry and combine the histological assessment with serological evaluations.
timeFrame: Visit 2 (week 1)
Secondary outcomes:
measure: 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
timeFrame: weeks 1, 24, 52 and 24 weeks post-treatment
measure: 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
timeFrame: weeks 24 and 52, 24 weeks post-treatment
measure: To evaluate percentage of patients with with HBsAg loss and/or HBsAg seroconversion
timeFrame: weeks 24, 52 and 24 weeks post-treatment
measure: 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
timeFrame: Visit 2 (week 1)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
city: Peking
country: China
facility: First Hospital of Peking University
city: Peking
country: China
facility: Peking University People's Hospital
city: Shanghai
country: China
facility: Ruijin Hospital, Affiliated to 2nd Medical university
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
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.