Clinical trial NCT02826070: EFFORT Further Extension Study
Official title: Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Major Science and Technology Special Project of China Twelfth-Five-Year Project
name: Novartis
First posted: 2016-07-07
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.


Eligibility criteria: Inclusion Criteria:

1. Patients who completed EFFORT extension study.
2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA \<9 Log copies/mL and ALT ≥2×ULN.
3. Patients who are willing to participate in the further extension study.
4. Patient is willing and able to comply with the study drug regimen and all other study requirements.
5. Patients must give written informed consent before any assessment is performed.

Exclusion Criteria:

1. Poor compliance judged by investigators

Primary outcomes:
measure: Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score).
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Incidence of adverse effect at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients with glomerular filtration rate (GFR) shifting to >90 mL/min/1.73 m2 for patients with GFR <90 mL/min/1.73 m2 at baseline of EFFORT study at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group
timeFrame: week 48, week 96
measure: Percentage of patients who re-achieved ALT normalization and HBV DNA <300 copies/mL in the patients retreated who developed hepatitis flare after stopping treatment in off-treatment group
timeFrame: week 96
measure: Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group
timeFrame: week 48, week 96
measure: Percentage of hepatitis flare at week 48 and 96 in off-treatment group
timeFrame: week 48, week 96
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital Of China
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: BeiJing YouAn Hospital ,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of infectious disease, First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Beijing University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated of ChongQing University of Medical Science
state: Chongqing
city: Guangzhou
country: China
facility: Department of Infectious Disease, Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: No. 8 People's Hospital In GuangZhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Hospital of Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South Univrsity
state: Hunan
city: Nanjing
country: China
facility: No.81 Hospital of PLA
state: Jiangsu
city: Changchun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: Shengyang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: JiNan Infectious Diseases Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital affiliated to Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: XiAn
country: China
facility: Tangdu Hospital
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou
role: PRINCIPAL_INVESTIGATOR
References: