Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Dragon-Ex
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
1 other identifier
interventional
360
1 country
16
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 9, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedJune 19, 2014
June 1, 2014
3.3 years
April 9, 2013
June 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Week 144
Secondary Outcomes (4)
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Week 48 & 96 & 144
Study Arms (2)
Group I
ACTIVE COMPARATORoral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Group II
ACTIVE COMPARATORoral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who completed the 104-week Dragon study.
- Subjects who are willing to participate the extension study.
You may not qualify if:
- Subjects who could not compliance with the protocol judged by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached To The Capital Medical University
Beijing, Beijing Municipality, China
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People's Hospital Under Beijnig University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong, China
GuangDong Provincial People's hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central-South Univrsity
Changsha, Hunan, China
First Hospital .Jilin Unniversity
Changchun, Jilin, China
ShengJing Hospital of China Medical University
Shengyang, Liaoning, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, China
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 33500704DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinlin Hou, MD
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2013
First Posted
April 11, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2016
Last Updated
June 19, 2014
Record last verified: 2014-06