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

Primary Purpose

Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir
Entecavir, Adefovir
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 Hepatitis B focused on measuring chronic hepatitis B, inadequate response, NUC therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female aged 18-65 years;
  • Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
  • Serum HBsAg positive and ALT<10ULN at study screening;
  • Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

  • History of viral breakthrough or genotypic resistance on previous therapy;
  • History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
  • Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
  • Other protocol defined exclusion criteria.

Sites / Locations

  • Beijing Ditan Hospita
  • 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 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

oral entecavir 1mg daily for 104 weeks

oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks

oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Outcomes

Primary Outcome Measures

proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104

Secondary Outcome Measures

serum HBV DNA reduction from baseline at week 104
The proportion of subjects with ALT normalization at week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104
The proportion of subject with HBsAg loss and seroconversion at week 104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104

Full Information

First Posted
February 16, 2011
Last Updated
October 28, 2013
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01341743
Brief Title
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Official Title
A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir 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
Hepatitis B
Keywords
chronic hepatitis B, inadequate response, NUC therapy

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
A
Arm Type
Active Comparator
Arm Description
oral entecavir 1mg daily for 104 weeks
Arm Title
B
Arm Type
Active Comparator
Arm Description
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Arm Title
C
Arm Type
Active Comparator
Arm Description
oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Intervention Type
Drug
Intervention Name(s)
Entecavir
Intervention Description
patients will receive oral entecavir 1mg, daily for 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Entecavir, Adefovir
Intervention Description
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Intervention Type
Drug
Intervention Name(s)
Entecavir, Adefovir
Intervention Description
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Primary Outcome Measure Information:
Title
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
Time Frame
week 104
Secondary Outcome Measure Information:
Title
serum HBV DNA reduction from baseline at week 104
Time Frame
week 104
Title
The proportion of subjects with ALT normalization at week 104
Time Frame
week104
Title
The proportion of subjects with HBeAg loss and seroconversion at week 104
Time Frame
week104
Title
The proportion of subject with HBsAg loss and seroconversion at week 104
Time Frame
week104
Title
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
Time Frame
week104

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: Male or female aged 18-65 years; Capable of understanding and signing the informed consent. Willing to comply with the study requirements; Serum HBsAg positive and ALT<10ULN at study screening; Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment; Exclusion Criteria: History of viral breakthrough or genotypic resistance on previous therapy; History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC; Other protocol defined exclusion criteria.
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 Hospita
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
ShenYang
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

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

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