Clinical trial NCT01829685: Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Official title: A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Inadequate Response
Nucleos(t)Ide Analogues Treatment
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Major Science and Technology Special Project of China Eleventh Five-year
First posted: 2013-04-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy


Eligibility criteria: Inclusion Criteria:

* Subjects who completed the 104-week Dragon study.
* Subjects who are willing to participate the extension study.

Exclusion Criteria:

* Subjects who could not compliance with the protocol judged by investigators

Primary outcomes:
measure: Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
timeFrame: Week 144
Secondary outcomes:
measure: Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
timeFrame: Week 48 & 96
measure: The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
timeFrame: Week 48 & 96 &144
measure: Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
timeFrame: Week 48 & 96 & 144
measure: Percentage of patients with ALT normalization at week 48/96/144
timeFrame: Week 48 & 96 & 144
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Attached To The 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 Under Beijnig University
state: Beijing
city: FuZhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: FoShan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Department of Infectious Disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: GuangDong Provincial People's hospital
state: Guangdong
city: NanNing
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
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: Changchun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: Shengyang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
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
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li Y, Pan CQ, Ji S, Yan G, Cheng J, Liu S, Xing H. Serum IL-21 levels predict HBeAg decline during rescue therapy in patients with partial response to nucleos(t)ide analogues. Exp Ther Med. 2021 Mar;21(3):216. doi: 10.3892/etm.2021.9648. Epub 2021 Jan 15.