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Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy (Dragon-Ex)

Primary Purpose

Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir, Adefovir
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Ditan Hospital
  • Beijing Friendship Hospital Attached To The Capital Medical University
  • Department of infectious disease, First Hospital of Peking University
  • People's Hospital Under Beijnig University
  • The First Affiliated Hospital of Fujian Medical University
  • The First People's Hospital of Foshan
  • Department of Infectious Disease, Nanfang Hospital
  • GuangDong Provincial People's hospital
  • First Affiliated Hospital of Guangxi Medical University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Xiangya Hospital Central-South Univrsity
  • First Hospital .Jilin Unniversity
  • ShengJing Hospital of China Medical University
  • Changhai Hospital affiliated to Second Military Medical University
  • Huashan Hospital，Fudan University
  • Shanghai Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks

oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Outcomes

Primary Outcome Measures

Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group

Secondary Outcome Measures

Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Percentage of patients with ALT normalization at week 48/96/144

Full Information

First Posted
April 9, 2013
Last Updated
June 17, 2014
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year
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1. Study Identification

Unique Protocol Identification Number
NCT01829685
Brief Title
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Acronym
Dragon-Ex
Official Title
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Intervention Type
Drug
Intervention Name(s)
Entecavir, Adefovir
Primary Outcome Measure Information:
Title
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Time Frame
Week 144
Secondary Outcome Measure Information:
Title
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Time Frame
Week 48 & 96
Title
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Time Frame
Week 48 & 96 &144
Title
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time Frame
Week 48 & 96 & 144
Title
Percentage of patients with ALT normalization at week 48/96/144
Time Frame
Week 48 & 96 & 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital Attached To The Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Department of infectious disease, First Hospital of Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
People's Hospital Under Beijnig University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
FuZhou
State/Province
Fujian
Country
China
Facility Name
The First People's Hospital of Foshan
City
FoShan
State/Province
Guangdong
Country
China
Facility Name
Department of Infectious Disease, Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
GuangDong Provincial People's hospital
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
NanNing
State/Province
Guangxi
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital Central-South Univrsity
City
Changsha
State/Province
Hunan
Country
China
Facility Name
First Hospital .Jilin Unniversity
City
Changchun
State/Province
Jilin
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
Shengyang
State/Province
Liaoning
Country
China
Facility Name
Changhai Hospital affiliated to Second Military Medical University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huashan Hospital，Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33500704
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.
Results Reference
derived

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Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

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